FDA 510(k) Glossary · regulatory

510(k) Clearance

510(k) clearance is the FDA authorization granted to a medical device after a successful 510(k) premarket notification review. Clearance is distinct from FDA approval - it means the device is substantially equivalent to a legally marketed predicate, not that safety and effectiveness have been independently demonstrated through clinical trials.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
165,719 of 166,200 submissions (99.7%) in the dataset have received 510(k) clearance. Average review time for cleared devices: ~129 days.

Definition

A 510(k) clearance - formally a "Substantially Equivalent determination" - is the FDA authorization that allows a medical device manufacturer to market their device in the United States following a successful 510(k) premarket notification review. Clearance is issued when the FDA concludes the device is substantially equivalent to a legally marketed predicate device.

Clearance vs Approval

The distinction between clearance and approval is legally and clinically significant:

Feature510(k) ClearancePMA Approval
Legal standardSubstantially equivalent to predicateSafe and effective (independent evidence)
Clinical trials requiredGenerally noYes
Device classClass I/IIClass III
U.S. Supreme Court caseMedtronic v. Lohr (1996)Riegel v. Medtronic (2008)

Clearance Decision Codes

CodeMeaning
SESESubstantially Equivalent (standard)
SESK, SESU, SEKD, SESP, SESDSubstantially Equivalent (variants)
DENGNot Substantially Equivalent (denial)

Dataset Insights

Of 166,200 submissions in the dataset, 165,719 (99.7%) received clearance. The average review time for cleared devices is approximately 129 days. Browse all cleared devices in the 510k Database.

Related Terms

510(k) Premarket Notification - Substantial Equivalence - Not Substantially Equivalent - Predicate Device

Frequently Asked Questions

510(k) clearance is the FDA's authorization to market a Class II medical device in the United States, granted after the FDA determines the device is substantially equivalent to a legally marketed predicate device. Clearance means the device can be marketed; it does not mean the FDA has independently evaluated the device's safety and effectiveness through clinical trials.

510(k) clearance is based on substantial equivalence to a predicate - the FDA determines the new device is similar enough to a previously marketed device to be cleared. FDA approval (through the PMA process for Class III devices) requires independent scientific evidence, typically from clinical trials, that the device is safe and effective. The distinction matters legally and commercially.

In the 510k Database dataset, cleared devices have decision codes beginning with 'SE' (Substantially Equivalent): SESE, SESK, SESU, SEKD, SESP, or SESD. The K-number serves as the unique identifier for each cleared submission. Denied submissions have decision code DENG (Not Substantially Equivalent).

A 510(k) clearance number (K-number) follows the format K + 2-digit year + 4-digit sequential number. For example, K243854 is the 3,854th submission filed in 2024. The K-number serves as the permanent identifier for the clearance in the FDA's records and in the 510k Database.