FDA 510(k) Glossary · pathway

510(k) Premarket Notification

510(k) Premarket Notification is the FDA regulatory pathway under which manufacturers demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, enabling clearance for marketing in the United States without clinical trials in most cases. It is the most commonly used premarket pathway for medical devices.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
166,200 510(k) submissions tracked in the dataset from 1976 to 2025, with 165,719 cleared (99.7%) and an average review time of ~129 days.

Definition

The 510(k) Premarket Notification is the primary regulatory pathway for Class II medical devices in the United States. Named after Section 510(k) of the Federal Food, Drug, and Cosmetic Act, it requires manufacturers to notify the FDA at least 90 days before marketing a new device and to demonstrate substantial equivalence to a legally marketed predicate device.

Legal Basis

The 510(k) pathway was established by the Medical Device Amendments of 1976, signed by President Gerald Ford on May 28, 1976. The amendments created a three-class risk-based regulatory framework. Class II devices - which represent the majority of 510(k) submissions - are subject to general and special controls and must demonstrate substantial equivalence to a predicate to receive clearance.

Submission Types

TypeUse Case
Traditional 510(k)Standard format for most new devices
Abbreviated 510(k)Devices relying on FDA-recognized standards or special controls
Special 510(k)Modifications to a manufacturer's own previously cleared device

Review Outcomes

Following review, the FDA issues one of three outcomes:

  • Substantially Equivalent (SE) - device is cleared for marketing.
  • Not Substantially Equivalent (NSE) - decision code DENG; device cannot be marketed as submitted.
  • Additional Information Request - FDA requires more data before making a determination.

Dataset Insights

MetricValue
Total records in dataset (1976-2025)166,200
Cleared submissions165,719 (99.7%)
NSE determinations464 (0.28%)
Distinct manufacturers33,307
FDA review panels20
Average review time (cleared)~129 days
Submissions with clinical trial link188
Submissions with third-party review3,434
Submissions with PCCP authorization91

FDA References

Related Terms

Substantial Equivalence - Predicate Device - Not Substantially Equivalent - De Novo Classification - Third-Party Review - PCCP

Frequently Asked Questions

A 510(k) Premarket Notification is a submission to the FDA demonstrating that a new medical device is substantially equivalent to a legally marketed predicate device. When the FDA determines substantial equivalence, it issues a clearance - not an approval - allowing the device to be marketed in the United States. The pathway is named after Section 510(k) of the Federal Food, Drug, and Cosmetic Act.

510(k) clearance means the FDA has determined the device is substantially equivalent to a predicate and may be marketed. FDA approval - required for Class III devices through the Premarket Approval (PMA) process - requires clinical evidence of safety and effectiveness and is a more rigorous standard. The U.S. Supreme Court noted in Medtronic v. Lohr (1996) that 510(k) focuses on equivalence, not safety.

The FDA has a statutory 90-day review target for 510(k) submissions, but actual review times vary. Based on 510k Database records, the average review time for cleared devices is approximately 129 days across all panels. Dental and Chemistry panels have the fastest average times (~88 days); Obstetrics/Gynecology is the slowest (~160 days).

The FDA accepts three 510(k) submission types: (1) Traditional 510(k) - the standard format for most devices; (2) Abbreviated 510(k) - for devices relying on FDA-recognized standards or special controls; and (3) Special 510(k) - for modifications to a manufacturer's own previously cleared device.