Is 510(k) clearance the same as FDA approval?

No. Clearance means FDA acknowledged the device is substantially equivalent to a legally-marketed predicate. Approval, via the PMA pathway, means FDA evaluated safety and effectiveness from scratch. Marketing copy that calls a cleared device "FDA-approved" is technically incorrect and has drawn FDA warning letters.

How long does a 510(k) review take?

The statutory FDA review target is 90 days. In practice, average total time-to-decision is closer to 150–180 days when you include clock pauses for Additional Information requests. Some K-numbers in our corpus took more than two years.

What is substantial equivalence?

Substantial equivalence rests on two prongs: 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 and are supported by performance data. If either prong breaks, the predicate fails and the applicant needs a different predicate or a different regulatory pathway.

Who decides whether a device clears?

A reviewer at the Center for Devices and Radiological Health (CDRH), working under one of the device advisory panels (Cardiovascular, Orthopedic, Radiology, and so on). The reviewer issues one of three outcomes: SE (substantially equivalent, cleared), NSE (not substantially equivalent, not cleared), or an Additional Information request that pauses the review clock.

How many 510(k)s does FDA clear each year?

Roughly 3,800 to 4,200 new 510(k) clearances per year. Class II devices account for about 95% of the 510(k) pathway, with the rest split across Class I (subject to general controls) and a small number of Class III legacy devices.

How 510(k) Clearance Works

The first thing to get straight: FDA does not approve 510(k) devices. It clears them. The distinction matters, and not only rhetorically. Clearance means FDA has acknowledged the new device is substantially equivalent to one already on the market. Approval (PMA) means FDA has evaluated safety and effectiveness from scratch. Different pathway, different legal standard, different evidentiary requirements.

Roughly 95% of Class II devices enter the US market through 510(k). As of the most recent FDA bulk export, this site indexes 174,693 cleared devices dating back to 1976. New clearances post at a rate of around 3,800–4,200 per year.

The mechanics

A 510(k) submission is filed by the manufacturer — FDA calls them the applicant, which is the label we use across the site. The submission claims the device is substantially equivalent (SE) to a predicate. A predicate is a legally marketed device, almost always itself cleared through an earlier 510(k).

Substantial equivalence rests on two prongs:

Same intended use as the predicate.
Same technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness — and are backed by performance data.

Either prong breaks, the predicate doesn't work and the applicant needs a different predicate or a different pathway (De Novo, PMA).

Submissions land at the Center for Devices and Radiological Health (CDRH). A reviewer in one of the device advisory panels (Cardiovascular, Orthopedic, Radiology, General & Plastic Surgery, and so on — browse them via product code on the homepage) works through the file and can return one of three outcomes:

SE: substantially equivalent. Cleared. Device can be legally marketed.
NSE: not substantially equivalent. Not cleared. De Novo or PMA becomes the next option.
Additional Information request. The clock pauses while the applicant supplies more data, then resumes on receipt.

The statutory FDA review target is 90 days. The lived reality runs longer. Average total time-to-decision in recent years has been closer to 150–180 days when you account for AI-clock pauses. Outliers go much further: some K-numbers in our corpus took more than two years start-to-finish.

What actually gets filed

A typical 510(k) package includes:

Cover letter
Form FDA 3514 (the standardized metadata form)
Indications for use
510(k) summary (or statement) — the only piece that is public by default
Device description, intended use, substantial-equivalence comparison table
Performance data: bench testing, biocompatibility, sometimes animal, sometimes clinical
Labeling and instructions for use
Sterilization, shelf-life, and biocompatibility details if applicable
Software documentation if applicable
Cybersecurity documentation if applicable (increasingly a default for any device with connectivity)

When you pull a K-number from openFDA and the statement_or_summary field is populated, it is usually a URL pointing at that summary PDF. A value of "statement" indicates the applicant filed a summary but it isn't posted.

Clearance is not approval

Marketing copy routinely calls a cleared Class II device "FDA-approved." It is not. FDA has issued warning letters over this exact phrasing. If your device is cleared, say cleared. If it's approved (via PMA), say approved. If it's 510(k)-exempt, say neither.

The logic: approval implies FDA evaluated the device directly for safety and effectiveness. Clearance implies FDA acknowledged substantial equivalence to a predicate. That predicate was cleared because of its own predicate. The chain runs back to devices legally marketed before the 1976 Medical Device Amendments that created the 510(k) pathway in the first place.

What to look for on a device page

Every 510(k) detail page on this site shows the same core fields FDA publishes:

K-number — assigned ID. Format: K followed by six digits.
Applicant — company that filed. Links to their full clearance history.
Product code — three-letter FDA classification. Every product code has its own page on the site.
Device class — I, II, or III. Drives regulatory burden.
Advisory panel — which CDRH panel reviewed it.
Date received / decision date — review-clock bookends.
Decision — SE, NSE, etc.

If you want to work backward from a marketed device to its clearance, the fastest path is usually: find the manufacturer name, use search for their clearances, match on device name. The mapping is not always one-to-one. The same device is often cleared under multiple K-numbers over its lifetime — labeling changes, new indications, minor design updates each trigger their own filing.

Frequently asked questions

Is 510(k) clearance the same as FDA approval?: No. Clearance means FDA acknowledged the device is substantially equivalent to a legally-marketed predicate. Approval, via the PMA pathway, means FDA evaluated safety and effectiveness from scratch. Marketing copy that calls a cleared device "FDA-approved" is technically incorrect and has drawn FDA warning letters.
How long does a 510(k) review take?: The statutory FDA review target is 90 days. In practice, average total time-to-decision is closer to 150–180 days when you include clock pauses for Additional Information requests. Some K-numbers in our corpus took more than two years.
What is substantial equivalence?: Substantial equivalence rests on two prongs: 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 and are supported by performance data. If either prong breaks, the predicate fails and the applicant needs a different predicate or a different regulatory pathway.
Who decides whether a device clears?: A reviewer at the Center for Devices and Radiological Health (CDRH), working under one of the device advisory panels (Cardiovascular, Orthopedic, Radiology, and so on). The reviewer issues one of three outcomes: SE (substantially equivalent, cleared), NSE (not substantially equivalent, not cleared), or an Additional Information request that pauses the review clock.
How many 510(k)s does FDA clear each year?: Roughly 3,800 to 4,200 new 510(k) clearances per year. Class II devices account for about 95% of the 510(k) pathway, with the rest split across Class I (subject to general controls) and a small number of Class III legacy devices.

Last updated 2026-04-23.