US FDA 510K SubmissionSupport for Medical Device Manufacturers
From your first predicate search to your clearance letter. NexorTest gives startups one team for 510(k) regulatory strategy, testing, eSTAR preparation and FDA responses, so you reach the US market on a timeline and budget your investors can plan around.
FDA’s review goal for a 510(k) decision
FY2027 small business 510(k) fee (standard: $28,653)
Price is dynamic and changes every year
Mandatory electronic format for every 510(k)
Strategy, testing, submission and FDA responses
What Is an FDA 510(k)?
A 510(k), or premarket notification, is the submission a manufacturer sends to the US Food and Drug Administration (FDA) to show that a new medical device is substantially equivalent to a legally marketed device, called the predicate. It is required under section 510(k) of the FD&C Act and 21 CFR 807 for most Class II and some Class I devices. You cannot sell the device in the US until FDA issues a clearance letter.
What "substantially equivalent" means
Your device has the same intended use as the predicate, and either the same technological characteristics or different ones that do not raise new questions of safety and effectiveness. You prove this with a side-by-side comparison and with performance data such as bench, biocompatibility, electrical safety, software and, sometimes, clinical testing.
Key 510(k) facts
- The 510(k) is the most common US route to market: FDA clears around 3,000 510(k)s a year, far more than De Novo or PMA
- All 510(k)s must be submitted in the FDA eSTAR electronic template
- FDA’s goal is a decision within 90 FDA review days, with the clock paused while you answer questions
- Clearance is not “FDA approval”. Only PMA devices are “approved”, so use “FDA cleared” in marketing
Does Your Device Need a 510(k), De Novo or PMA?
Your pathway depends on device risk class and whether a suitable predicate exists. Search FDA’s product classification database for your device type to find its class, product code and regulation number. If a predicate exists, and it is substantially equivalent, you file a 510(k). If the device is new and low-to-moderate risk with no predicate, you file a De Novo. High-risk Class III devices need a PMA.
| Pathway | When it applies | FY2027 FDA fee (small business) | FDA review goal |
|---|---|---|---|
| 510(k) exempt | Most Class I and some Class II devices listed as exempt | $0 (registration fee still due) | None. Register and list |
| 510(k) | Class II (and some Class I) with a suitable predicate | $28,653 ($7,163) | 90 FDA days |
| De Novo | Novel low-to-moderate-risk device with no predicate | $191,020 ($47,755) | 150 FDA days |
| PMA | Class III, life-sustaining or high-risk devices | Significantly higher; first PMA may be waived for small businesses | 180 FDA days (plus panel if needed) |
Fees from FDA’s MDUFA FY2027 schedule, valid 1 October 2026 – 30 September 2027. Not sure which pathway fits? Our free readiness assessment answers that in writing.
510(k) Support
First-time founders don’t fail at the 510(k) because their device is unsafe. They lose months to the wrong predicate, testing done in the wrong order, and Additional Information letters they didn’t see coming. We plan around the constraints startups actually have.
"We have 18 months of runway."
A clearance plan tied to your funding milestones
A dated regulatory roadmap and budget per phase, written so your board and investors can follow it. We sequence testing so cash is not spent on work that a Pre-Sub might change.
"We don't have a regulatory team."
Your outsourced regulatory department
We act as your regulatory affairs function, from strategy through FDA correspondence, until you are ready to hire, and we train your first RA hire.
"Investors are asking about FDA risk."
Due-diligence-ready documentation
Pathway rationale, predicate analysis and a testing gap list investors can review. That turns “FDA risk” from an unknown into a plan.
"Testing labs, consultants, designers: too many vendors."
Testing and regulatory under one roof
Our labs run EMC/EMI, environmental, cybersecurity and usability testing, and we coordinate biocompatibility and sterilization. That means one plan, one timeline and no gaps between vendors.
"Fees are eating our budget."
Small Business Determination
Startups with gross receipts of $100M or less (including affiliates) can cut the 510(k) fee from $28,653 to $7,163. We prepare your Small Business Determination request before you submit.
"We're based outside the US."
Foreign startup support
Single documentation set can be re-used for other country submissions such as EU, UK, CDSCO.
Our FDA 510(k) Consulting Services
Use the full end-to-end service or only the pieces you need.
Regulatory strategy & classification including 513(g) support
- Device classification, product code and regulation number
- 510(k) vs De Novo vs exempt decision
- Intended use and indications for use wording
- Regulatory roadmap with budget and timeline
Predicate search & substantial equivalence
- Predicate and reference device search in FDA databases
- Side-by-side SE comparison table
- Gap analysis of technological differences
- Recall and adverse event review of predicates
Pre-Submission (Q-Sub)
- Pre-Sub package and targeted questions
- FDA meeting preparation and attendance
- Agreement on test plans before you spend on testing
- Meeting minutes and strategy update
Performance testing plan & execution
- Test plan mapped to FDA-recognized standards
- Electrical safety, EMC, environmental, usability and cybersecurity testing
- Biocompatibility, sterilization and shelf-life coordination
- Test reports formatted for FDA review
Design controls & QMSR
- Design History File (DHF) set-up for startups
- Risk management to ISO 14971
- Quality system aligned with FDA's QMSR (ISO 13485-based, effective Feb 2026)
- Software (IEC 62304) and cybersecurity files
eSTAR preparation & submission
- Complete eSTAR authoring and internal technical review
- Labeling, IFU and 510(k) Summary
- User fee payment and CDRH Portal submission
- Technical screening support
FDA interaction & AI responses
- Interactive review responses
- Additional Information (AI) letter response strategy
- Supplementary testing coordination
- Teleconferences with FDA reviewers
Launch & post-market compliance
- Establishment registration and device listing
- UDI and GUDID set-up
- Complaint handling, MDR (adverse event) reporting and recalls
- Change assessment: new 510(k) or letter to file
The 510(k) Process
The 510(k) process has seven steps: classify the device, choose a predicate, optionally hold a Pre-Submission meeting with FDA, complete performance testing, prepare the eSTAR, submit and respond to FDA questions, then register and list after clearance. For a typical Class II device, a startup should plan roughly 9–15 months from kick-off to clearance, mostly driven by testing.
Readiness assessment & classification
We confirm the class, product code and pathway, review what you already have and give you a written gap list, timeline and budget.
Predicate selection & SE strategy
We identify the strongest predicate and build the substantial equivalence argument, including how to handle any technological differences.
Pre-Submission meeting with FDA
For novel features, new test methods or software and AI, a Pre-Sub gets FDA’s written feedback before you commit to testing. There is no FDA fee for a Pre-Sub.
Design controls, risk management & testing
We finalise design inputs and the risk file, then run or coordinate bench, safety, EMC, biocompatibility, software, cybersecurity and usability testing.
eSTAR preparation & submission
We author the eSTAR, run an internal “mock FDA” review, help you pay the user fee and submit through the CDRH Portal.
FDA review & Additional Information response
FDA runs a technical screening within 15 days, then a substantive review. If FDA sends an Additional Information request, you have 180 calendar days to respond. We draft and manage every response.
Clearance, registration & listing
After the clearance letter, we register your establishment, list the device, set up UDI and put post-market processes in place so you can sell in the US.
Traditional, Special and Abbreviated 510(k): Which One?
| Type | Use it when | Typical FDA review |
|---|---|---|
| Traditional 510(k) | Your first submission for a new device. Most startups use this route. | 90 FDA days |
| Special 510(k) | You changed your own already-cleared device and the change can be assessed with well-established methods. | 30 days |
| Abbreviated 510(k) | You rely on FDA guidance documents, special controls or recognised consensus standards to show equivalence. | 90 FDA days |
| Third Party Review | The device type is eligible for FDA’s 510(k) Third Party Review Program, where an accredited organization reviews first. | Often faster. No FDA user fee, but the reviewer charges its own fee |
510(k) Submission Requirements and Testing
A 510(k) eSTAR includes the device description, intended use and indications, a substantial equivalence comparison, proposed labeling, and performance data. Which tests you need depends on the device: typically electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), software (IEC 62304), cybersecurity, usability (IEC 62366-1), sterilization and shelf life.
| Evidence | Key standard / guidance | Needed when | NexorTest |
|---|---|---|---|
| Electrical safety | IEC 60601-1 (+ particular standards) | Powered / electrical devices | Test & manage |
| EMC / EMI | IEC 60601-1-2 | Powered / electrical devices | In-house lab |
| Environmental & transport | IEC 60068, ASTM D4169 | Most physical devices | In-house lab |
| Software documentation | IEC 62304, FDA software guidance (Basic / Enhanced) | Any device with software or firmware | Full support |
| Cybersecurity | FD&C Act §524B, FDA premarket cybersecurity guidance | Connected devices, including SaMD | Pen testing & SBOM |
| Usability / human factors | IEC 62366-1, FDA HF guidance | User-interface risk | In-house |
| Biocompatibility | ISO 10993 series | Patient-contacting devices | Coordinated with GLP labs |
| Sterilization & shelf life | ISO 11135 / 11137 / 17665, ASTM F1980 | Sterile or time-limited devices | Coordinated |
| Bench performance | Device-specific standards, FDA guidance | All devices | Protocol & report |
How Much Does a 510(k) Cost in 2026–2027?
The FDA fee for a 510(k) in fiscal year 2027 (1 Oct 2026 – 30 Sep 2027) is $28,653, or $7,163 for a qualified small business. You also pay a $13,785 annual establishment registration fee when you start selling. Total startup budgets also include testing and consulting, and testing is usually the largest cost.
| Cost item | Amount | Notes |
|---|---|---|
| FDA 510(k) user fee: standard | $28,653 | FY2027 rate |
| FDA 510(k) user fee: small business | $7,163 | Requires an approved Small Business Determination (≤ $100M gross receipts) |
| Annual establishment registration | $13,785 | No small business discount. Due when you register to sell |
| Pre-Submission meeting | $0 | No FDA fee |
| Testing | Varies widely | Depends on device type and technology. Scoped in your readiness assessment |
| NexorTest consulting | Fixed fee per phase | Quoted after the free readiness assessment, with no open-ended hourly billing |
Why 510(k) Submissions Get Delayed and How We Prevent It
- Weak predicate choice: differences in technology that raise new questions. Fix: predicate scoring and a Pre-Sub when differences are material.
- Incomplete performance testing: missing FDA-recognized standards or untested worst-case configurations. Fix: a test plan mapped to the FDA recognized standards database before testing starts.
- Software and cybersecurity gaps: missing documentation level, SBOM or threat model. Fix: IEC 62304 and §524B files built alongside development.
- Inconsistent indications for use: wording that differs between labeling, IFU and the comparison table. Fix: one controlled source of wording for intended use.
- Biocompatibility rationale gaps: no justification for skipped endpoints. Fix: a biological evaluation plan to ISO 10993-1 and FDA’s guidance.
- Technical screening holds: missing eSTAR attachments. Fix: an internal technical screen before every submission.
Why Medical Device Manufacturers Choose NexorTest as Their 510(k) Consultant
Design, testing and regulatory in one team
Most 510(k) consultants only write the submission. We also help design the device, run the testing and fix what testing finds, so no time is lost between vendors.
One file for multiple markets
Your 510(k) evidence is structured so it can be reused for CE marking under EU MDR, UKCA, CDSCO (India), Health Canada and MDSAP.
Medical Device Manufacturer-friendly commercials
Phased, fixed-fee engagements aligned to funding rounds, and a free readiness assessment before you commit.
Software, AI and connected devices
In-house IEC 62304, cybersecurity and AI/ML regulatory expertise for SaMD and connected device 510(k)s, including Predetermined Change Control Plans (PCCPs).
Offices in the US, India, Europe, UK and UAE
US support during US business hours, with engineering capacity that keeps costs within Medical Device Manufacturers’ budgets.
Founder-level attention
Every Medical Device Manufacturer engagement has a named senior regulatory lead, not a rotating junior team.
FDA 510(k) Frequently Asked Questions
What is a 510(k) clearance?
A 510(k) clearance is FDA’s decision that a medical device is substantially equivalent to a legally marketed predicate device, allowing it to be sold in the United States. It is issued as a clearance letter with a K number, for example K261234, which appears in FDA’s public 510(k) database.
How long does it take to get 510(k) clearance?
FDA’s goal is to decide within 90 FDA review days. The clock stops while you answer FDA’s questions, so total calendar time is usually longer. Including preparation and testing, startups should plan roughly 9–15 months from project start to clearance for a typical Class II device.
Can a startup qualify for the FDA small business fee?
Yes. Companies with gross receipts or sales of $100 million or less, including affiliates, can apply for a Small Business Determination (SBD) through the CDRH Portal. An approved SBD reduces the 510(k) fee by about 75%. Apply before you submit the 510(k), because the reduced fee only applies once FDA has approved your SBD. Pre-revenue startups qualify too.
What is a predicate device and how do I find one?
A predicate is a legally marketed US device that your device is compared against to show substantial equivalence. You find candidates in FDA’s 510(k) database and product classification database by product code, then compare intended use, technology and performance. Choosing the right predicate is the single biggest factor in 510(k) success.
What if there is no predicate for my device?
If no predicate exists and the device is low-to-moderate risk, you can request De Novo classification instead. A granted De Novo creates a new device type that later devices can use as a predicate. High-risk devices without a predicate need a PMA.
Do I need clinical data for a 510(k)?
Most 510(k)s are cleared with bench, laboratory and non-clinical data only. FDA may ask for clinical data when technological differences from the predicate cannot be resolved with non-clinical testing. A Pre-Submission meeting is the best way to confirm this early.
Should a startup hold a Pre-Submission (Pre-Sub) meeting?
Usually yes, if your device has novel technology, software or AI, a new test method, or uncertain predicate equivalence. A Pre-Sub is free, gives you FDA’s written feedback on your plan, and prevents costly re-testing. It typically takes about 70–90 days from request to meeting.
What is eSTAR?
eSTAR (electronic Submission Template And Resource) is FDA’s mandatory interactive PDF template for 510(k) and De Novo submissions. It guides you through every required section and is submitted through the CDRH Portal. Submissions not in eSTAR format are not accepted.
Does FDA inspect my facility before 510(k) clearance?
Generally no. FDA does not routinely inspect before clearing a 510(k). However, you must comply with FDA’s Quality Management System Regulation (QMSR, 21 CFR 820, aligned with ISO 13485 since February 2026), including design controls, and FDA can inspect you after you start selling.
Find Out How Close You Are to 510(k) Clearance
Our free 510(k) readiness assessment confirms your pathway, shortlists predicates, lists the testing you need and gives you a timeline and budget you can take to your investors.