FDA 510k Clearance for Medical Devices and IVDs
FDA 510k clearance is the US marketing authorisation for most Class II and some Class I devices. You get it by proving in a premarket notification that your device is substantially equivalent to a legally marketed predicate. I3CGLOBAL classifies the device, selects the predicate, plans the testing and submits the eSTAR for you.
FDA 510k at a Glance
- What it is: a premarket notification under section 510(k) of the FD&C Act showing substantial equivalence to a legally marketed predicate device
- Who needs it: most Class II and some Class I devices; most Class III devices need PMA instead
- Format: eSTAR electronic submission, mandatory since 1 October 2023
- FDA review goal: 90 FDA days under MDUFA, with the clock paused during Additional Information holds
- FY2027 user fee: $28,653, or $7,163 for qualified small businesses
- Outcome: a substantial equivalence letter and a public listing in the FDA 510(k) database under a K number
What Is FDA 510k Clearance?
An FDA 510k is a premarket notification, named after section 510(k) of the Federal Food, Drug and Cosmetic Act. It tells FDA, at least 90 days before you market a device, that the device is at least as safe and effective as a legally marketed device that does not need premarket approval. The rules are in 21 CFR Part 807 Subpart E.
When FDA agrees that the device is substantially equivalent (SE) to its predicate, it issues a clearance letter and the device is “510(k) cleared”. Only then can you sell it in the United States. If FDA finds it not substantially equivalent (NSE), the device moves to De Novo or premarket approval.
FDA 510k Meaning in One Sentence
FDA 510k clearance means FDA has reviewed your comparison with an existing cleared device and agrees the new device has the same intended use and either the same technology or different technology that raises no new questions of safety and effectiveness.
Clearance Letter and 510(k) Number
Every submission gets a 510(k) number, or K number, when FDA receives it: the letter K, two digits for the year and a four-digit sequence, for example K260123. The acknowledgment letter is not a clearance. The clearance is the SE decision letter, which includes your Indications for Use and the 510(k) Summary or Statement. After clearance, you complete establishment registration and device listing before shipping.
FDA 510k Clearance vs FDA Approval vs De Novo
People often say “510k approval”, but FDA only approves devices through premarket approval (PMA). A 510(k) device is cleared, and a De Novo device is granted. The difference matters on labels, websites and investor documents.
| FDA 510k | De Novo | PMA | |
|---|---|---|---|
| Outcome | Cleared | Granted | Approved |
| Typical risk | Class II, some Class I | Novel low to moderate risk, no predicate | Class III |
| Standard | Substantial equivalence to a predicate | Reasonable assurance with special controls | Valid scientific evidence of safety and effectiveness |
| Clinical data | Sometimes | Often | Usually |
| MDUFA review goal | 90 FDA days | 150 FDA days | 180 FDA days |
Is There an FDA 510k Certificate?
No. FDA does not issue a 510(k) certificate or a “US FDA 510k certification”. Your proof is the SE letter and the public entry in the FDA 510(k) database. Documents sold as FDA certificates are not issued by FDA; see our note on US FDA certificates. For approval of high-risk devices, read about premarket approval (PMA), and for the wider picture, the FDA approval process.
Who Needs an FDA 510k?
Under 21 CFR 807.81 you need a 510(k) before you market a device in the US when:
- You are introducing a device to the US market for the first time
- You change the intended use of a device you already market
- You make a change to design, materials, energy source, software or labeling that could significantly affect safety or effectiveness
The obligation sits with whoever places the device on the US market: domestic manufacturers, specification developers, foreign manufacturers and exporters, and repackagers or relabelers who significantly change labeling or the device. Typical 510k medical devices include infusion pumps, powered wheelchairs, surgical gloves, blood glucose meters, ultrasound systems and many software products. Foreign companies also need a US FDA agent.
510k Exemptions
Most Class I devices and some Class II devices are exempt from 510(k), but only within the limitations in the “.9” section of each classification panel. A change in intended use or a new technology can remove the exemption. Exempt devices still need registration, listing and compliance with the quality system and labeling rules.
Find Your Product Code and Regulation Number
Search the FDA product classification database by device name to find the three-letter product code, the regulation number and whether a 510(k) is required. Our guides on FDA medical device classification and FDA IVD classification walk through borderline cases.
3 Types of FDA 510k Submissions
FDA accepts three types of 510(k). Picking the right one early saves weeks of review time.
| Type | When to use it | What makes it different |
|---|---|---|
| Traditional 510(k) | Any device, including first submissions | Full comparison and test data; the default route |
| Special 510(k) | A change to your own cleared device | Relies on design control activities; FDA aims to decide within 30 days |
| Abbreviated 510(k) | Device covered by guidance, special controls or recognised standards | Uses summary reports and declarations of conformity |
Any type can be sent through the 510(k) Third Party Review Program for eligible device types. For product-specific routes, see the active device 510k, non-active device 510k, IVD 510k workflow and SaMD 510k process. Personal protective products such as gowns, gloves and masks are covered in our 510k services for PPE.
FDA 510k Requirements and Documentation
Since 1 October 2023, every 510(k) must be submitted electronically using the eSTAR template, unless exempted. A complete file usually includes:
- Device description, indications for use and a substantial equivalence comparison with the predicate
- Proposed labeling and instructions for use that meet FDA labeling requirements
- Biocompatibility for patient-contacting materials
- Sterilisation validation, shelf life and packaging data where relevant
- Electrical safety and EMC testing for powered devices
- Software documentation and, for connected devices, cybersecurity evidence
- Bench performance testing, human factors where needed, and animal or clinical data only if bench data is not enough
- 510(k) Summary or 510(k) Statement, Truthful and Accurate statement and user fee cover sheet
For IVDs, add analytical and FDA IVD clinical evidence studies, and plan a CLIA waiver if the test is meant for point-of-care use.
How to Search the FDA 510k Database
The FDA 510(k) premarket notification database lists every cleared 510(k) with its decision letter and summary. FDA adds new clearances weekly. It is the best free tool for checking a competitor or finding a predicate.
- Open the databaseGo to the FDA premarket notification database on accessdata.fda.gov.
- Search by one fieldEnter a 510(k) number, applicant name, device name or three-letter product code. Fewer fields give more results.
- Filter by decision dateNarrow the results to recent clearances, which reflect current FDA expectations.
- Open the recordCheck the product code, regulation number, decision and review panel.
- Read the summaryThe 510(k) Summary PDF shows the predicate used and the testing performed.
How to Read a 510(k) Number
| Part | Example | Meaning |
|---|---|---|
| Prefix | K | Premarket notification |
| Year | 26 | Calendar year FDA received the submission |
| Sequence | 0123 | Order of receipt that year |
Numbers that start with DEN are De Novo requests, and P numbers are PMAs. A K number alone does not prove clearance: always check the decision field.
Predicate Device and Substantial Equivalence
A predicate is a legally marketed device: one cleared through 510(k), granted De Novo, reclassified, or marketed before 28 May 1976. Your device is substantially equivalent when it has the same intended use and either the same technological characteristics, or different ones that do not raise new questions of safety and effectiveness and are supported by data.
- Same intended use and a close match on indications for use
- Same or similar design, materials, energy source and software functions
- Predicate not recalled for design-related safety issues
- Performance data that bridges every difference
See our 8-criteria guide to predicate device selection. If no suitable predicate exists, a De Novo request is usually the better route.
FDA 510k Clearance Process in 5 Steps
This is the path we follow for every 510(k) project, from first classification to the SE letter.
- Classify the deviceConfirm the product code, regulation number, device class and whether a 510(k) is required.
- Select the predicateCompare candidates in the 510(k) database and agree a test strategy, with a Pre-Submission if needed.
- Complete the testingRun biocompatibility, electrical safety, EMC, software, sterilisation and performance testing.
- Submit the eSTARCompile the eSTAR, pay the user fee and submit through the FDA portal.
- Clearance and listingAnswer FDA questions, receive the SE letter, then register the establishment and list the device.
FDA 510k Review Timeline
| Milestone | Timing |
|---|---|
| Technical screening of the eSTAR | Within 15 calendar days of receipt |
| Substantive interaction or Additional Information request | Within 60 calendar days |
| MDUFA decision goal | 90 FDA days (clock stops during AI hold) |
| Time to answer an AI request | 180 calendar days, no extensions |
See FDA’s 510(k) submission process for details. In practice, most clearances take four to eight months from submission. The step-by-step submission guide is on our FDA 510k submission page.
FDA 510k Fees for FY2027
For submissions from 1 October 2026 to 30 September 2027, the FDA user fee is $28,653, or $7,163 for a qualified small business with gross receipts of $100 million or less. The annual establishment registration fee is $13,785. See the full FDA 510k fee breakdown or estimate your budget with the 510k cost calculator.
Our FDA 510k Services
Whether it is your first 510k medical device or a change to a cleared product, we prepare the complete file and stay responsible until the clearance letter is issued. To see who does the work and how we engage, visit our FDA 510k consultants page.
Regulatory strategy
Classification, product code, 510(k) type and Pre-Submission planning.
Predicate search
Database research and a substantial equivalence comparison FDA can follow.
Test planning
Test plans with recognised standards and lab coordination.
eSTAR preparation
Writing and compiling every eSTAR section, plus the 510(k) Summary.
FDA communication
Answers to technical screening and Additional Information requests.
Why I3CGLOBAL?
Our regulatory and technical teams work on FDA 510(k), De Novo, EU MDR and IVDR projects for manufacturers worldwide, with offices in the USA, UK, India, Germany, Portugal, South Korea and Malaysia. We assemble the full file ourselves rather than review your drafts. Planning Europe too? Compare the US route with CE marking.
Common Reasons for FDA 510k Delays and NSE Decisions
These are the issues behind most Additional Information requests and not substantially equivalent decisions:
- Predicate with a different intended use or one that was itself never properly cleared
- Differences in technology with no performance data to bridge them
- Testing to outdated standards or without a rationale for the test plan
- Incomplete biocompatibility or sterilisation evidence
- Software or cybersecurity documentation below the expected level
- Labeling claims that go beyond the indications for use
- Late or incomplete answers to the AI request, leading to withdrawal after 180 days
A Pre-Submission meeting before testing starts is the cheapest way to avoid most of these problems.
Work with I3CGLOBAL
Get Your FDA 510k Clearance Plan
Send us your device description and intended use. We will confirm the classification, suggest predicates and give you a fixed-scope proposal with timelines.
- Classification and 510(k) type
- Predicate shortlist
- Test and submission roadmap
Request a 510k proposal
Tell us about your device and target launch date.
FAQs
FDA 510k: Frequently Asked Questions
What is FDA 510k clearance?
FDA 510k clearance is FDA’s decision that a device is substantially equivalent to a legally marketed predicate device, based on a premarket notification under section 510(k) of the FD&C Act. Once cleared, the device can be marketed in the United States.
Is it 510k or 501k?
It is 510k, from section 510(k) of the Federal Food, Drug and Cosmetic Act. “501k” is a common misspelling and is not an FDA pathway.
What is the difference between FDA 510k and PMA?
A 510(k) shows substantial equivalence to an existing device and leads to clearance. A PMA is for most Class III devices and must prove safety and effectiveness with valid scientific evidence, usually clinical data, and leads to approval.
Which devices are exempt from 510k?
Most Class I devices and some Class II devices are exempt, within the limitations in the .9 section of each classification panel. Exempt devices still need establishment registration, device listing and compliance with other FDA requirements.
How do I find a device’s product code and regulation number?
Search the FDA product classification database by device name. Each record shows the product code, regulation number, device class and whether a 510(k) is required.
How long does FDA take to review a 510k?
FDA’s goal is a decision within 90 FDA days. The clock stops while the submission is on hold for Additional Information, so most clearances take four to eight months in total.
How much does an FDA 510k cost?
The FDA user fee for FY2027 is $28,653, or $7,163 for qualified small businesses. Testing and consulting costs depend on the device and are usually higher than the user fee.
How do I check if a device is 510k cleared?
Search the FDA 510(k) premarket notification database by 510(k) number, company or device name, and check that the decision is substantially equivalent.
What if my device is innovative and has no predicate?
If no predicate exists and the device is low to moderate risk, you can request De Novo classification. Higher-risk devices need a PMA.