FDA Cleared vs Approved vs Granted: 510(k), PMA and De Novo

TL;DR

"FDA cleared," "FDA approved" and "FDA granted" are not synonyms. Each names a different legal decision.

• Cleared means FDA found a device substantially equivalent to a legally marketed predicate through a 510(k).
• Approved means FDA approved a premarket approval (PMA) application after finding valid scientific evidence that the device is safe and effective.
• Granted means FDA granted a De Novo request and created a new Class I or Class II classification for a novel device that has no predicate.

The volumes are lopsided. Pure Global's analysis of the official openFDA exports covers calendar year 2025: FDA decided 3,198 510(k) clearances, granted 27 De Novo requests and approved 38 original PMAs. Clearances were 98.0% of those new marketing authorizations. Over 2016 to 2025 the split is almost identical: 30,669 clearances, 322 De Novo grants and 281 original PMA approvals. ^{1 2}

Getting the word right matters. FDA's regulation says a 510(k) clearance "does not in any way denote official approval of the device," and a claim that creates "an impression of official approval" is misbranding. ³

Cleared, approved and granted in one table

The three outcomes differ in the question FDA answers, the evidence it expects, the fee and the review clock.

Fees apply from 1 October 2026 to 30 September 2027. ⁴ Review goals are from the MDUFA V commitment letter. "FDA days" exclude time a submission is on hold waiting for the sponsor, so calendar times run longer. ⁵

What "FDA cleared" means: the 510(k)

A cleared device has been found substantially equivalent to a device already legally on the US market. It has not been found safe and effective on its own evidence.

FDA describes a 510(k) as a submission "to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device." It also explains what follows: the submitter must receive an order "which finds the device to be substantially equivalent," and "this order 'clears' the device for commercial distribution." ⁶

Substantial equivalence means the same intended use as the predicate, plus one of two things. Either the device has the same technological characteristics, or its different characteristics "do not raise different questions of safety and effectiveness" and the data show it is as safe and effective. Clinical data are sometimes needed, but most 510(k)s rely on bench, biocompatibility, software, electrical safety and performance testing against recognized standards.

There are three kinds of 510(k): Traditional, Special and Abbreviated. FDA generally reviews Special 510(k)s, which cover certain changes to a manufacturer's own cleared device, within 30 days. ⁷ All 510(k)s must use the eSTAR electronic template unless exempted, a rule in force since 1 October 2023. ⁸

What 2025 looked like in the openFDA export:

Third-party 510(k)s are a subset that overlaps the three types. No FDA user fee is charged when an accredited third party submits the 510(k). ⁹

If FDA finds a device not substantially equivalent, the device is Class III by default. The applicant may submit a new 510(k), request De Novo classification, petition for reclassification or file a PMA.

What "FDA approved" means: the PMA

Approval is FDA's most demanding device decision. It rests on the applicant's own evidence of safety and effectiveness, not on comparison to a predicate.

FDA calls the PMA "the most stringent type of device marketing application required by FDA." Approval "is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)." ¹⁰ In practice that usually means a pivotal clinical study under an investigational device exemption. FDA also inspects manufacturing before approval and may convene an advisory panel.

PMAs are rare but they never stop generating work. In the openFDA PMA export:

• FDA approved 38 original PMAs in 2025, with a median of 271.5 calendar days from receipt to approval. Over 2021 to 2025 it approved 145 originals, and 61 of them (42%) were cardiovascular devices.
• The same year FDA decided 2,182 PMA supplements. 1,380 were 30-day notices for manufacturing changes, 244 were real-time supplements, 377 were 180-day supplements and 30 were panel-track supplements.

Each supplement type has its own FY2027 fee: $509,386 for a panel-track supplement, $95,510 for a 180-day supplement, $44,571 for a real-time supplement and $10,188 for a 30-day notice. A Class III approval also brings an annual periodic reporting fee of $22,286. The full original PMA fee is $636,732, or $159,183 for a small business with gross receipts of $100 million or less.

Approval attaches to the device, its labeling and its manufacturing process as reviewed. Changes affecting safety or effectiveness need an approved supplement before they are made. ¹¹ PMA devices are also inspected after approval: FDA's inspection program for device manufacturers schedules PMA post-market inspections 8 to 12 months after approval. ¹²

What "FDA granted" means: De Novo

A De Novo grant authorizes a novel device and, in the same step, creates a new device type that later products can follow through a 510(k).

The De Novo pathway exists for devices of low or moderate risk that have no predicate. Without it they would be Class III by default. FDA calls De Novo "a risk-based classification process," and when it agrees it intends to "grant the De Novo request and establish a new classification regulation for the new device type." ¹³

The procedure is codified in 21 CFR 860 Subpart D. Its rule took effect on 3 January 2022. Under 21 CFR 860.200(b) a request may follow a not-substantially-equivalent decision on a 510(k). It may also be filed directly when a person determines there is no legally marketed device on which to base substantial equivalence. ¹⁴ The statute then makes the granted device a predicate. Devices classified through De Novo "may be marketed and used as predicates for future premarket notification [510(k)] submissions." Since 1 October 2025, De Novo requests must also use eSTAR.

The numbers from FDA's De Novo grants, as published in the openFDA 510(k) export and cross-checked against FDA's De Novo database:

• 322 grants from 2016 to 2025, and 27 in 2025. 2023 and 2024 had 47 each. ¹⁵
• From 2021 to 2025, 173 grants took a median of 318 calendar days from receipt to decision. The middle half ranged from 233 to 469 days.
• Neurology (20), general hospital (17), cardiovascular (16) and microbiology (15) led the 2021 to 2025 grants.

One famous example shows why the wording matters. Apple's ECG app is often described as "FDA cleared." FDA's database records it as De Novo DEN180044, decided on 11 September 2018 with the outcome "granted." ¹⁶

How long each route takes in practice

On calendar days from receipt to decision, a Special 510(k) is about ten times faster than a De Novo, and a Traditional 510(k) about half the time of an original PMA.

These medians measure total elapsed time, including the days FDA's clock is stopped while the sponsor answers questions. They describe outcomes, not FDA performance. They also include only successful decisions, because the public exports publish clearances, grants and approvals but not refusals or withdrawals. For planning, add preparation time before submission: test programs for a 510(k), and clinical studies for most PMAs and many De Novo requests.

How to choose between 510(k), De Novo and PMA

The route follows from the device's classification and from whether a valid predicate exists. Work through it in this order.

1. Find the product code and classification regulation. If a regulation covers your device, its class and exemption status set the default route. Our guide to FDA medical device classification walks through the six steps.
2. If the device is Class I or II and not exempt, look for a predicate with the same intended use. A predicate with a different product code, or one cleared for a narrower indication, is a warning sign.
3. If no predicate fits and the risk is low or moderate, plan a De Novo. Budget for performance data that can support new special controls. Consider a Pre-Submission first, since FDA charges no fee for it. See our Q-Sub and Pre-Sub guide.
4. If the device is Class III, plan a PMA, usually with an investigational device exemption study, and an inspection-ready quality system under the QMSR.
5. If you cannot tell, ask. A 513(g) request for information costs $8,596 in FY2027, and FDA intends to respond within 60 days. The answer is not a final classification decision. ¹⁷

Our 510(k) consulting and PMA consulting pages describe the submission work for each route.

How to describe your FDA status correctly

Marketing copy, sales decks, labels and investor materials should use the word that matches the decision letter.

FDA's consumer guidance is blunt about the last two rows: "The FDA does not issue any type of device registration certificates." It also says a device listing entry "does not denote approval, clearance, or authorization." ^{18 19}

"FDA authorized" is a safe umbrella term. FDA itself writes that a De Novo device "was granted marketing authorization." But use the specific word whenever space allows, because buyers, hospital value-analysis committees and regulators in other countries read the difference.

Statuses that are not cleared, approved or granted

• Breakthrough Device designation. As of 30 June 2026, FDA's device and biologics centers had granted 1,320 Breakthrough Device designations. A designation gives sponsors more interaction with FDA during development. The device still needs a 510(k), De Novo or PMA decision before marketing. ²⁰
• Humanitarian Device Exemption. A humanitarian use device treats or diagnoses a condition affecting not more than 8,000 people in the United States each year. It is approved under an HDE on probable benefit rather than proof of effectiveness, with limits on profit. ²¹
• 510(k)-exempt. Most Class I and some Class II devices reach the market with registration and listing only. That is lawful marketing, not clearance.
• Registered establishment. Every manufacturer registers annually ($13,785 for FY2027), whatever its devices' status. See our establishment registration guide.

How Pure Global helps

We choose the route, find and defend predicates, prepare eSTAR submissions, and run 513(g) and Pre-Submission requests for 510(k), De Novo and PMA programs. As your US Agent we keep registration and listing current. Our regulatory data team maintains the 510(k), De Novo and PMA records behind this analysis. You can search them in Pure Global AI's free FDA database, which helps when you are screening predicates or benchmarking review times. ²² Contact our team to plan your submission.

How we built the numbers

• Sources: the official openFDA 510(k) and PMA bulk exports dated 12 October 2026. Pure Global's life-science data lake keeps them with SHA-256 lineage. Counts are by calendar year of the decision date.
• 510(k) clearances: K-numbers with a substantially equivalent decision code. The openFDA export publishes cleared 510(k)s only.
• De Novo grants: the DEN records included in the same export, all with the decision code "granted." FDA's De Novo database returned identical counts for 2023 (47), 2024 (47) and 2025 (27).
• Original PMA approvals: PMA numbers with no supplement number and the decision code "APPR." Supplements are counted separately by supplement type.
• Review times: calendar days from the date received to the decision date. Year-to-date 2026 data run through early October and are excluded from the annual comparisons.