--- title: "510(k), 510(k) Premarket Notification | MedTech Terms" description: "FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. 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FDA approval refers to Premarket Approval (PMA), which is used for high-risk Class III devices and requires clinical evidence of safety and effectiveness." } }, { "@type": "Question", "name": "How long does a 510(k) take?", "acceptedAnswer": { "@type": "Answer", "text": "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." } }, { "@type": "Question", "name": "What is the difference between a Traditional, Special, and Abbreviated 510(k)?", "acceptedAnswer": { "@type": "Answer", "text": "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." } }, { "@type": "Question", "name": "How much does a 510(k) cost?", "acceptedAnswer": { "@type": "Answer", "text": "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." } }, { "@type": "Question", "name": "Do I need a 510(k) for software changes?", "acceptedAnswer": { "@type": "Answer", "text": "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)." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. 510(k) Premarket Notification [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)510(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 Cyber](/authors/christian-espinosa) Last 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](/terms/safe-note) and effective - that is, substantially equivalent - to a legally marketed device that is not subject to [premarket approval](/terms/pma) (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](/terms/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](/terms/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 1 ### 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](/terms/substantial-equivalence) in technological characteristics, and provide bench performance data per ISO 80601-2-61. Outcome FDA clears the device in ~5 months, allowing the new module to ship under the existing brand without a full [PMA](/terms/pma). 2 ### Software-only SaMD diagnostic algorithm SaMD product manager A startup files a 510(k) for an ECG analysis [SaMD](/terms/samd), citing a cleared algorithm as predicate. They submit [IEC 62304](/terms/iec-62304) software documentation, performance testing on a held-out clinical dataset, and a cybersecurity package addressing FDA's [524B](/terms/section-524b) requirements. Outcome Cleared as a Class II [SaMD](/terms/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 Is a 510(k) the same as FDA approval? No. A 510(k) results in FDA clearance based on [substantial equivalence](/terms/substantial-equivalence) to a [predicate device](/terms/predicate-device). FDA approval refers to [Premarket Approval](/terms/pma) (PMA), which is used for high-risk Class III devices and requires clinical evidence of safety and effectiveness. How long does a 510(k) take? What is the difference between a Traditional, Special, and Abbreviated 510(k)? How much does a 510(k) cost? Do I need a 510(k) for software changes? ## Cross-references ### Governed by Regulations or standards this term must comply with. - [ Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [ Quality Management System Regulation(QMSR) ](/terms/qmsr) ### Uses Concepts or artefacts this term builds on. - [ Predicate Device ](/terms/predicate-device) - [ Substantial Equivalence(SE) ](/terms/substantial-equivalence) - [ eSTAR ](/terms/estar) ### Contains Sub-elements or required artefacts of this term. - [ Special 510(k)(Special 510(k)) ](/terms/special-510k) - [ Abbreviated 510(k) ](/terms/abbreviated-510k) ### Precedes Comes before in a typical workflow or lifecycle. - [ Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) ### Often confused with Distinct concept frequently mistaken for this one. - [ Premarket Approval(PMA) PMA is approval; 510(k) is clearance. ](/terms/pma) - [ De Novo Classification Request(De Novo) De Novo is for novel devices lacking a predicate. ](/terms/de-novo) ### See also Closely related context worth reading. - [ Letter to File(LTF) ](/terms/letter-to-file) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Regulatory Predicate Device A legally marketed device used as the comparator in a 510(k) submission. ](/terms/predicate-device)[ Regulatory Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. ](/terms/substantial-equivalence) ### 510(k) Fundamentals · From this learning path [ Regulatory Refuse to Accept(RTA) FDA administrative decision that a submission is incomplete and won't be substantively reviewed. ](/terms/rta?from=510k-fundamentals)[ Regulatory Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. ](/terms/indications-for-use?from=510k-fundamentals)[ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. ](/terms/intended-use?from=510k-fundamentals) ### De Novo & Breakthrough Pathways · From this learning path [ Regulatory Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. ](/terms/breakthrough-device?from=de-novo-and-breakthrough)[ Regulatory Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. ](/terms/combination-product?from=de-novo-and-breakthrough)[ Regulatory Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. ](/terms/q-sub?from=de-novo-and-breakthrough)[ Commercialization Pre-Submission Meeting(Q-Sub) Formal FDA feedback request prior to a marketing or IDE submission. ](/terms/pre-submission?from=de-novo-and-breakthrough) ### Founder & Investor Primer · From this learning path [ Commercialization TAM / SAM / SOM Market sizing framework: total, serviceable available, and serviceable obtainable. Adjacent lesson ](/terms/tam-sam-som?from=founder-and-investor-primer)[ Investment & Finance Capitalization Table(Cap Table) Ledger of all securities issued by a company and who owns them. ](/terms/cap-table?from=founder-and-investor-primer)[ Investment & Finance Convertible Note Short-term debt that converts into equity at a future financing round. ](/terms/convertible-note?from=founder-and-investor-primer)[ Investment & Finance Due Diligence Investigation of a company before an investment, financing, or acquisition. ](/terms/due-diligence?from=founder-and-investor-primer) Cited by Where this term appears across MedTech Terms. Learning paths (3) - [510(k) Fundamentals](/paths/510k-fundamentals)Lesson 1 of 7 - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 9 of 11 - [Founder & Investor Primer](/paths/founder-and-investor-primer)Lesson 2 of 16 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) Comparisons (1) - [510(k) vs PMA](/compare/510k-vs-pma)vs Premarket Approval ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 eCFR· 1 1. [1 510(k) Premarket Notification Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k) 2. [2 The 510(k) Program Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k) 3. [3 21 CFR Part 807 Subpart E Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on a 510(k) submission? We support cybersecurity content for 510(k) submissions - SBOM, threat model, risk assessment, and the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym 510(k) Sources 3 Use cases 2 Updated 5/5/2026 [Compare with another term](/compare?a=510k) Learn in 60 seconds Card Lesson Quiz 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. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Substantial Equivalence(SE) ](/terms/substantial-equivalence) - [Predicate Device ](/terms/predicate-device) - [Refuse to Accept(RTA) ](/terms/rta) You may also need Auto-suggested from Regulatory and shared keywords. - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Emergency Use Authorization(EUA) ](/terms/eua) - [Modular PMA ](/terms/pma-modular) - [Special 510(k)(Special 510(k)) ](/terms/special-510k) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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