--- title: "510(k) Summary vs 510(k) Statement… | MedTech Terms" description: "Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k-summary-vs-statement#term", "name": "510(k) Summary vs 510(k) Statement", "description": "Every 510(k) submission must include either a 510(k) Summary or a 510(k) Statement. A 510(k) Summary describes the safety and effectiveness information FDA reviewed and is posted publicly on the FDA 510(k) Premarket Notification database after clearance, it is the document competitors and customers read to understand a cleared device. A 510(k) Statement is a certification by the submitter that, upon request, they will provide safety and effectiveness information described in the submission to any person within 30 days. Most submitters file Summaries; Statements are used when the submitter prefers not to publish a summary upfront but is willing to respond to individual requests.", "url": "https://medtechterms.com/terms/510k-summary-vs-statement", "termCode": "510k-summary-vs-statement", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/510k-summary-vs-statement#article", "headline": "510(k) Summary vs 510(k) Statement", "description": "Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.", "url": "https://medtechterms.com/terms/510k-summary-vs-statement", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/510k-summary-vs-statement" }, "about": { "@id": "https://medtechterms.com/terms/510k-summary-vs-statement#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "510(k) Summary vs 510(k) Statement, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-06-20", "dateModified": "2026-06-20", "citation": [ { "@type": "CreativeWork", "name": "21 CFR 807.92 - 510(k) Summary", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.92", "publisher": { "@type": "Organization", "name": "eCFR" } }, { "@type": "CreativeWork", "name": "21 CFR 807.93 - 510(k) Statement", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.93", "publisher": { "@type": "Organization", "name": "eCFR" } }, { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/abbreviated-510k#term", "name": "Abbreviated 510(k)", "url": "https://medtechterms.com/terms/abbreviated-510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/special-510k#term", "name": "Special 510(k)", "alternateName": "Special 510(k)", "url": "https://medtechterms.com/terms/special-510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/third-party-510k#term", "name": "Third-Party Review of 510(k)", "alternateName": "3P 510(k)", "url": "https://medtechterms.com/terms/third-party-510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/predicate-device#term", "name": "Predicate Device", "url": "https://medtechterms.com/terms/predicate-device" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/substantial-equivalence#term", "name": "Substantial Equivalence", "alternateName": "SE", "url": "https://medtechterms.com/terms/substantial-equivalence" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "510(k) Summary vs 510(k) Statement", "item": "https://medtechterms.com/terms/510k-summary-vs-statement" } ] } ] } --- [ 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) Summary vs 510(k) Statement [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle) # 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition Every 510(k) submission must include either a 510(k) Summary or a 510(k) Statement. A 510(k) Summary describes the safety and effectiveness information FDA reviewed and is posted publicly on the FDA [510(k) Premarket Notification](/terms/510k) database after clearance, it is the document competitors and customers read to understand a cleared device. A 510(k) Statement is a certification by the submitter that, upon request, they will provide safety and effectiveness information described in the submission to any person within 30 days. Most submitters file Summaries; Statements are used when the submitter prefers not to publish a summary upfront but is willing to respond to individual requests. What the regulation says 21 CFR 807.92 (510(k) Summary content requirements) and 21 CFR 807.93 (510(k) Statement requirements). FDA's 510(k) database hosts every Summary; Statements appear in the database as a noted designation only. ## What this means in practice Choice of Summary vs Statement has competitive and commercial implications. A well-written 510(k) Summary serves as marketing collateral, it's often the first technical document a hospital or competitor sees. A Statement provides less public visibility but creates an obligation to fulfill information requests within 30 days, which most companies underestimate. For high-profile or controversial products, the choice is often strategic. Common pitfalls - • Filing a Summary that is too thin, FDA expects substantial detail about indications, technological characteristics, performance testing, and substantial equivalence rationale. - • Filing a Statement and then being unable to respond to information requests within 30 days, failure constitutes a violation. - • Treating the Summary as confidential, it is public the day clearance is issued. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory Predicate Device A legally marketed device used as the comparator in a 510(k) submission. ](/terms/predicate-device)[ Regulatory Special 510(k)(Special 510(k)) Streamlined 510(k) for modifications to a manufacturer's own legally marketed device. ](/terms/special-510k) ### More in Regulatory · Same category [ Regulatory Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. ](/terms/substantial-equivalence)[ Regulatory Third-Party Review of 510(k)(3P 510(k)) Program in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types. ](/terms/third-party-510k)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 2 FDA· 1 1. [1 21 CFR 807.92 - 510(k) Summary Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.92) 2. [2 21 CFR 807.93 - 510(k) Statement Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.93) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to 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 Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=510k-summary-vs-statement) Learn in 60 seconds Card Lesson Quiz Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. - · Choice of Summary vs Statement has competitive and commercial implications. - · A well-written 510(k) Summary serves as marketing collateral, it's often the first technical document a hospital or competitor sees. - · A Statement provides less public visibility but creates an obligation to fulfill information requests within 30 days, which most companies underestimate. Remember this Watch out: Filing a Summary that is too thin, FDA expects substantial detail about indications, technological characteristics, performance testing, and substantial equivalence rationale. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Abbreviated 510(k) ](/terms/abbreviated-510k) - [Special 510(k)(Special 510(k)) ](/terms/special-510k) - [Third-Party Review of 510(k)(3P 510(k)) ](/terms/third-party-510k) - [Predicate Device ](/terms/predicate-device) - [Substantial Equivalence(SE) ](/terms/substantial-equivalence) You may also need Auto-suggested from Regulatory and shared keywords. - [Device Master File(MAF) ](/terms/device-master-file) - [PMA Supplement Types ](/terms/pma-supplement-types) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [De Novo Classification Request(De Novo) ](/terms/de-novo) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ 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 Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)