How long does a 510(k) take?

The statutory FDA review clock is 90 days, but total time from submission to clearance commonly runs 3 to 9 months once Refuse to Accept review, Additional Information requests, and interactive review are included.

What is the difference between a Traditional, Special, and Abbreviated 510(k)?

Traditional is the default pathway. Special 510(k) is for modifications to a manufacturer's own cleared device where design controls fully evaluate the change. Abbreviated 510(k) relies on FDA guidance documents, special controls, or recognized consensus standards to streamline review.

How much does a 510(k) cost?

The main direct cost is the FDA user fee, which is updated annually and reduced for small businesses. Preparation costs (testing, consulting, writing) are typically far larger than the user fee itself.

Do I need a 510(k) for software changes?

It depends on whether the change could significantly affect safety or effectiveness. FDA's guidance on 510(k) modifications and the separate software modifications guidance provide decision logic; changes that alter indications, add cybersecurity risk, or introduce new algorithms often require a new 510(k).

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RegulatoryRegulated Pathways Global Markets510(k) /five-ten-kay/

510(k) Premarket Notification

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a device to be marketed is at least as safe and effective - that is, substantially equivalent - to a legally marketed device that is not subject to premarket approval (PMA).

What the regulation says

FDA reviewers look for clear side-by-side comparisons to the predicate, complete performance testing, and - when applicable - premarket cybersecurity documentation per Section 524B.

What this means in practice

Most Class II devices in the United States reach the market through the 510(k) pathway. A clearance (often called 'K number') is required before commercial distribution. Choice of predicate, indications for use, and performance testing are central to a successful submission.

Examples

A new infusion pump cleared as substantially equivalent to an existing pump.
A connected patient monitor citing a predicate plus added cybersecurity controls.

Use cases

2 scenarios

Updated patient monitor with a new pulse oximetry module

Regulatory Affairs lead

A Class II patient monitor manufacturer adds a third-party SpO₂ module. They identify their previous-generation monitor as the predicate, document substantial equivalence in technological characteristics, and provide bench performance data per ISO 80601-2-61.

OutcomeFDA clears the device in ~5 months, allowing the new module to ship under the existing brand without a full PMA.

Software-only SaMD diagnostic algorithm

SaMD product manager

A startup files a 510(k) for an ECG analysis SaMD, citing a cleared algorithm as predicate. They submit IEC 62304 software documentation, performance testing on a held-out clinical dataset, and a cybersecurity package addressing FDA's 524B requirements.

OutcomeCleared as a Class II SaMD; the team can begin commercial pilots with hospital systems.

Common pitfalls

•Treating 510(k) clearance as 'FDA approval' - it is a clearance based on equivalence, not an approval.
•Choosing a predicate with materially different indications, technology, or performance.
•Underestimating cybersecurity content now expected for software-containing devices.

Frequently asked questions

No. A 510(k) results in FDA clearance based on substantial equivalence to a predicate device. FDA approval refers to Premarket Approval (PMA), which is used for high-risk Class III devices and requires clinical evidence of safety and effectiveness.

Cross-references

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Uses

Concepts or artefacts this term builds on.

Contains

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Precedes

Comes before in a typical workflow or lifecycle.

Post-Market Surveillance(PMS)

Often confused with

Distinct concept frequently mistaken for this one.

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Primary references

3 sources

Link health: 3 verified· last checked 2026-06-20

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On this term

Category: Regulatory
Acronym: 510(k)
Sources: 3
Use cases: 2
Updated: 5/5/2026

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Learn in 60 seconds

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

·Most Class II devices in the United States reach the market through the 510(k) pathway.
·A clearance (often called 'K number') is required before commercial distribution.
·Choice of predicate, indications for use, and performance testing are central to a successful submission.

Remember this

Watch out: Treating 510(k) clearance as 'FDA approval' - it is a clearance based on equivalence, not an approval.

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