510(k) — Premarket Notification (United States)
A 510(k) is a premarket notification submitted to the U.S. Food and Drug Administration (FDA) to demonstrate that a device is substantially equivalent (SE) to a legally marketed predicate device that is not subject to PMA (21 CFR 807 Subpart E). When FDA finds SE, the device is cleared—not “approved” (PMA)—for U.S. commercial distribution. Most Class II and some Class I device types require a 510(k) unless specifically exempt by regulation.
Substantial equivalenceMost Class IICDRH revieweSTAR required
What 510(k) is (and isn’t)
- Is: A premarket submission showing SE to a predicate based on intended use and technology, supported by appropriate performance data.
- Is not: PMA; it is not an “approval.” FDA issues a Substantially Equivalent (SE) decision letter (device is “cleared”).
- Applies to: Generally Class II and some Class I device types; always verify the regulation number and product code for exemption status/limitations.
- Does not apply when: The device type is 510(k)-exempt, or PMA/De Novo is the correct pathway (e.g., no suitable predicate and low–moderate risk → consider De Novo).
Substantial equivalence (SE) — basics
- Predicate eligibility: A legally marketed U.S. device (e.g., previously 510(k)-cleared, De Novo-classified, or preamendments device).
- SE criteria (21 CFR 807.100): Same intended use and either (a) same technological characteristics, or (b) different technological characteristics that do not raise different questions of safety and effectiveness—supported by valid scientific evidence (bench, animal, and/or clinical performance as needed).
- Multiple/reference predicates: Multiple predicates and separate reference devices may be used when appropriate; “split predicates” (different intended uses across devices) are not acceptable.
Types of 510(k)
- Traditional 510(k): Standard format used for most devices.
- Special 510(k): For certain manufacturer’s own cleared devices when design control activities can evaluate the change; leverages the existing design history file.
- Abbreviated 510(k) / Safety and Performance Based Pathway: Uses guidance documents, special controls, and/or FDA-recognized standards or FDA-specified performance criteria to streamline evidence where applicable.
510(k) process — high-level
- 1) Confirm the pathway: Check the device classification/regulation and exemption status; if no valid predicate and risk is low–moderate, assess De Novo; Class III typically needs PMA.
- 2) Identify predicate & assess SE: Match intended use; compare technology; plan testing to address any new/different questions of safety and effectiveness.
- 3) Prepare content: Indications for use, device description, risk analysis, performance testing (bench/biocompatibility/sterilization/EMC&Electrical safety/usability/software/cybersecurity as applicable), labeling, and the required 510(k) Summary or Statement.
- 4) Format & submit: Use FDA’s structured eSTAR template via the CDRH Portal (eSTAR is required for nearly all 510(k) submissions).
- 5) Acceptance & substantive review: FDA conducts an acceptance review (administrative completeness) followed by substantive review; a Substantive Interaction typically occurs within ~60 calendar days to request additional information if needed.
- 6) Decision: FDA issues SE (cleared) or NSE. After clearance, complete establishment registration and device listing and maintain QMS/postmarket obligations.
Quick checks
- Exemptions: Many Class I and some Class II device types are 510(k)-exempt (often with limitations). Always verify the regulation number and product code.
- Notified Bodies? Not applicable in the U.S.; submissions go to FDA (CDRH/CBER as applicable).
- Timelines: Under MDUFA goals, FDA’s decision goal for 510(k) is ~90 FDA days; clock may pause for Additional Information (AI) requests.
Documentation pointers
- Use current FDA guidance for Refuse-to-Accept (acceptance checklist is integrated in eSTAR) and the content of premarket submissions for your technology area (software, SaMD, cybersecurity, biocompatibility, sterilization, EMC/electrical safety, usability).
- Map each special control and recognized standard to objective evidence; include complete test reports or declarations of conformity as appropriate.
- Labeling should match intended use and risk controls; ensure UDI/part 801 labeling rules are addressed in commercialization planning.
510(k) — FAQs
Is 510(k) “approval”?
No. A successful 510(k) results in an FDA clearance (SE decision). PMA devices receive “approval.”
Do all Class II devices need a 510(k)?
Most do, but some Class II device types are 510(k)-exempt (with limitations). Always check the specific regulation and product code.
Can I use multiple predicates?
Yes, when appropriate. You may also cite reference devices for supportive information, but you cannot “split” intended uses across predicates.
Is eSTAR mandatory?
Yes—FDA requires the electronic eSTAR template for nearly all 510(k) submissions; it embeds acceptance checks and speeds review logistics.
What happens after clearance?
Register your establishment, list the device, comply with QMS requirements (QMSR/ISO 13485), and meet postmarket obligations (e.g., MDR reporting, corrections/removals as applicable).
Predicate Device Selection Checklist
- Legally marketed? Confirm the predicate is cleared (510(k)), De Novo classified, or a valid pre-amendments device — not withdrawn or recalled.
- Same intended use? The predicate must match your device’s intended use statement in scope and population.
- Technological characteristics? Either identical or differences that do not raise new safety/effectiveness questions.
- Performance data available? Bench, biocompatibility, EMC/electrical safety, software/cybersecurity, or clinical data as needed to bridge gaps.
- Regulation & product code check: Verify on FDA’s product classification database; confirm device type is not 510(k)-exempt.
- Special controls? Identify all applicable special controls (21 CFR, FDA guidance) and map them to your evidence plan.
- Global fit: If pursuing EU MDR or other markets, ensure your chosen U.S. predicate aligns with equivalent international classification.
Tip: Choosing the wrong predicate is a leading cause of FDA Additional Information (AI) requests and delays. Need help? Contact CENIT Consulting to validate your predicate strategy before submission.
Predicate Selection — FAQs
What if no suitable predicate exists?
If your device has no valid predicate and presents low–to–moderate risk, consider the De Novo pathway. If risk is high (Class III) or special controls can’t mitigate risk, PMA may be required.
Can I mix intended uses across devices?
No. Split predicates (using one device for intended use and another for technology) are not acceptable. You may cite multiple predicates where appropriate, and separate reference devices to support testing rationale.
Does a De Novo device qualify as a predicate?
Yes. Once granted, a De Novo device becomes a legally marketed predicate for future 510(k)s within that new classification regulation/product code.
What if the predicate has recalls or safety issues?
Recalls don’t automatically disqualify a predicate, but you must address the issue and demonstrate your device mitigates the risk; otherwise FDA may determine NSE.
Should I use the newest cleared device as a predicate?
Newer can help alignment with current special controls and test methods, but the best predicate is the one that most closely matches your intended use and tech characteristics with the least need for bridging data.
510(k) Predicate Decision — Visual Guide
- Tip: If Steps 2–3 are marginal, request a Q-Sub (pre-submission) to validate your predicate strategy before testing.
- Reminder: Avoid split predicates; reference devices can support methods, not intended use.
Not sure about your predicate or De Novo vs 510(k)?
We’ll validate intended use, tech comparisons, test plans, and eSTAR structure—so your first FDA response isn’t an AI (Additional Information) request.