510(k) Premarket Notification

Key facts

Legal basis

FD&C Act Section 510(k); 21 CFR Part 807, Subpart E

Standard

Substantial equivalence to a legally marketed predicate device

Outcome

Clearance, not approval

Identifier

K followed by six digits, for example K123456

Electronic format

eSTAR template required since October 1, 2023

What is a 510(k)?

Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a device maker to notify the Food and Drug Administration (FDA) at least 90 days before marketing many new devices. The submission compares the device with a predicate, a device already legally on the U.S. market, to show that the new device is at least as safe and effective.

Most Class II devices need a 510(k), along with some Class I devices and a small number of Class III device types. Many Class I and some Class II devices are exempt.

FDA clears a 510(k); it does not approve it. Describing a cleared device as FDA approved is misleading.

How substantial equivalence works

A device is substantially equivalent when, compared with the predicate, it:

Evidence is often bench, biocompatibility, software and electrical safety testing, and some submissions include clinical data. The performance goal under the Medical Device User Fee Amendments (MDUFA) is a decision within 90 FDA review days, a clock that pauses while FDA waits for answers from the sponsor.

If FDA finds a device not substantially equivalent, it is placed in Class III by default, and the sponsor must seek Premarket Approval (PMA) or request De Novo classification.

• has the same intended use, and
• has the same technological characteristics, or has different technological characteristics that do not raise different questions of safety and effectiveness, with data showing it is as safe and effective.

Why the 510(k) matters

Clearance records are a detailed public map of the device market:

• Competitive mapping: 510(k) summaries name predicates, so analysts can trace product families and see which devices competitors compare themselves with.
• Launch timing: a clearance date marks when a device can be legally marketed in the U.S., a signal for market entry forecasts.
• Regulatory strategy: the choice of predicate and pathway drives the evidence, cost and time a new device needs.
• Liability: cleared devices do not receive the federal preemption of state-law claims that the Supreme Court recognized for PMA devices.

Criticism of the 510(k) pathway

Critics argue that chains of predicates let devices reach the market without clinical evidence of safety, and a 2011 Institute of Medicine report recommended replacing the process. FDA has kept the pathway while adding changes such as the Safety and Performance Based Pathway and mandatory electronic submissions.