How long does a 510(k) really take?

In short: FDA's review goal for a 510(k) is 90 "FDA days," but that clock pauses during additional-information holds — which most first submissions hit. Total elapsed time from project start to clearance commonly runs 6–12 months, per industry-cited estimates from regulatory consultancies. Preparation quality — predicate fit and documentation completeness — is what moves the total.

Two clocks, not one

The headline numbers describe two different clocks. FDA's MDUFA performance goal is a decision within 90 FDA days — but "FDA days" exclude time a submission spends on hold. When the agency issues an Additional Information (AI) request, the clock pauses until you respond (you have up to 180 days before the submission is treated as withdrawn), and most first-time submissions receive at least one AI request. FDA's published statistics report both "FDA days" and total calendar days, and the gap between the two is exactly why the "average review time" a founder reads off a dashboard can understate real elapsed time. The 6–12 month figure is scoped to the whole journey: total elapsed time from project start — predicate research, testing, documentation — through submission and any hold cycles to clearance.

What actually drives the total higher or lower

Predicate fit is the single biggest lever: a well-matched predicate with a clean equivalence argument moves through review with fewer AI requests, while a contested or loosely-matched predicate almost guarantees at least one hold cycle, each of which can add one to several months depending on how substantive the request is. Documentation completeness at submission — testing data, software documentation, cybersecurity evidence — matters nearly as much; gaps found during review cost more time than the same gaps would have cost to close before submitting.

What actually shortens it

A Pre-Submission meeting with FDA before you formally submit is the most reliable lever available: it surfaces predicate or testing concerns while they're still cheap to fix, rather than after the formal review clock has started. Teams that treat the Pre-Sub as optional overhead rather than a real part of the timeline tend to be the ones surprised by how long their "6–12 months" stretched.

Where next: Why Most 510(k)s Get an Information Request · How much does a 510(k) cost?

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