510(k) Premarket Notification
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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 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 scenariosUpdated patient monitor with a new pulse oximetry module
Regulatory Affairs leadA 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.
Software-only SaMD diagnostic algorithm
SaMD product managerA 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.
- •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
Cross-references
Governed by
Regulations or standards this term must comply with.
Uses
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Contains
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Precedes
Comes before in a typical workflow or lifecycle.
Often confused with
Distinct concept frequently mistaken for this one.
See also
Closely related context worth reading.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsPathway to classify novel low- to moderate-risk devices that lack a predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
A legally marketed device used as the comparator in a 510(k) submission.
The legal standard a 510(k) device must meet versus a predicate.
510(k) Fundamentals
· From this learning pathFDA administrative decision that a submission is incomplete and won't be substantively reviewed.
Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
The objective intent of the manufacturer regarding the use of the device.
De Novo & Breakthrough Pathways
· From this learning pathFDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
Product comprised of two or more regulated components - e.g., drug-device, biologic-device.
Voluntary mechanism to obtain FDA feedback before a formal premarket submission.
Formal FDA feedback request prior to a marketing or IDE submission.
Founder & Investor Primer
· From this learning pathMarket sizing framework: total, serviceable available, and serviceable obtainable.
Ledger of all securities issued by a company and who owns them.
Short-term debt that converts into equity at a future financing round.
Investigation of a company before an investment, financing, or acquisition.
Primary references
3 sources- 1
510(k) Premarket NotificationVerifiedFDAfda.gov
- 2
The 510(k) Program GuidanceVerifiedFDAfda.gov
- 3
21 CFR Part 807 Subpart EVerifiedeCFRecfr.gov
Inline markers like [1] jump to the matching reference above.