--- title: "Predicate Device, Definition | MedTech Terms" description: "A legally marketed device used as the comparator in a 510(k) submission. Plain-English Regulatory definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/predicate-device#term", "name": "Predicate Device", "description": "A predicate device is a legally marketed device to which a new device is compared in a 510(k) Premarket Notification to support a determination of substantial equivalence.", "url": "https://medtechterms.com/terms/predicate-device", "termCode": "predicate-device", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/predicate-device#article", "headline": "Predicate Device", "description": "A legally marketed device used as the comparator in a 510(k) submission.", "url": "https://medtechterms.com/terms/predicate-device", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/predicate-device" }, "about": { "@id": "https://medtechterms.com/terms/predicate-device#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Predicate Device, 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": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "Best Practices for Selecting a Predicate Device", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-selecting-predicate-device-support-premarket-notification-510k-submission", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "European Commission - Medical Devices", "url": "https://health.ec.europa.eu/medical-devices-sector_en", "publisher": { "@type": "Organization", "name": "European Commission" } } ], "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/substantial-equivalence#term", "name": "Substantial Equivalence", "alternateName": "SE", "url": "https://medtechterms.com/terms/substantial-equivalence" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/de-novo#term", "name": "De Novo Classification Request", "alternateName": "De Novo", "url": "https://medtechterms.com/terms/de-novo" } ] }, { "@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": "Predicate Device", "item": "https://medtechterms.com/terms/predicate-device" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/predicate-device#faq", "mainEntity": [ { "@type": "Question", "name": "What makes a device 'legally marketed' for predicate purposes?", "acceptedAnswer": { "@type": "Answer", "text": "A device is legally marketed if it was in commercial distribution before May 28, 1976 (preamendments device), or has been reclassified from Class III to Class II or I, or has been found substantially equivalent through the 510(k) process, or has been approved through a PMA or granted through a De Novo classification request." } }, { "@type": "Question", "name": "Can I use multiple predicate devices?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, it is possible to reference multiple predicate devices. This is common when a new device incorporates features or technologies from several existing devices. Each comparison must be clearly justified." } }, { "@type": "Question", "name": "What if no suitable predicate device exists?", "acceptedAnswer": { "@type": "Answer", "text": "If no suitable predicate device can be identified, the device may need to go through the De Novo classification process or a Premarket Approval (PMA) application, depending on its risk classification and novelty. This indicates a higher regulatory hurdle." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Predicate Device [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways) # Predicate Device A legally marketed device used as the comparator in a 510(k) submission. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A predicate device is a legally marketed device to which a new device is compared in a [510(k) Premarket Notification](/terms/510k) to support a determination of [substantial equivalence](/terms/substantial-equivalence). What the regulation says The FDA, under 21 CFR 807.92(a)(3), requires a medical device manufacturer to identify a predicate device that is legally marketed in the United States when submitting a [510(k) Premarket Notification](/terms/510k). The new device must be substantially equivalent to the predicate in terms of [intended use](/terms/intended-use), technology, and safety and effectiveness. The EU [MDR](/terms/mdr-reporting) does not use the term "predicate device" but has analogous provisions for demonstrating conformity, often through comparison to similar devices already on the market. ## What this means in practice Selecting an appropriate predicate is one of the most consequential decisions in a 510(k). An ill-chosen predicate can trigger a Not Substantially Equivalent (NSE) determination, requiring a [De Novo](/terms/de-novo) or [PMA](/terms/pma) pathway. ## Examples - A company developing a new surgical Stapler identifies an older model of surgical stapler from a different manufacturer that already has 510(k) clearance, using it as a predicate. - A manufacturer of a novel diagnostic imaging system uses a previously cleared MRI machine as a predicate, demonstrating similar intended use and fundamental scientific technology. - A startup creating an AI-powered diagnostic software lists a cleared, non-AI diagnostic software with the same intended use as its predicate to establish substantial equivalence in basic function, then addresses the AI-specific aspects. Common pitfalls - • Choosing a predicate device with different indications for use than the new device can lead to a finding of "Not Substantially Equivalent." - • Selecting a predicate that has been recalled or has known safety issues can jeopardize the 510(k) submission. - • Failing to adequately document the similarities and differences between the new device and the predicate can result in submission delays or rejection. - • Relying on a predicate device for which there is insufficient publicly available information can make substantial equivalence difficult to prove. - • Not considering the technological characteristics and performance data of the predicate can lead to an inappropriate comparison. ## Frequently asked questions What makes a device 'legally marketed' for predicate purposes? A device is legally marketed if it was in commercial distribution before May 28, 1976 (preamendments device), or has been reclassified from Class III to Class II or I, or has been found substantially equivalent through the 510(k) process, or has been approved through a [PMA](/terms/pma) or granted through a [De Novo classification request](/terms/de-novo). Can I use multiple predicate devices? What if no suitable predicate device exists? ## Cross-references ### Used by Things that build on this term. - [ 510(k) Premarket Notification(510(k)) ](/terms/510k) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. ](/terms/substantial-equivalence)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo) ### 510(k) Fundamentals · From this learning path [ Regulatory Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. Adjacent lesson ](/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)[ Regulatory Refuse to Accept(RTA) FDA administrative decision that a submission is incomplete and won't be substantively reviewed. ](/terms/rta?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 Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma?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) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [510(k) Fundamentals](/paths/510k-fundamentals)Lesson 2 of 7 - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 7 of 11 Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 European Commission· 1 1. [1 Best Practices for Selecting a Predicate Device Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-selecting-predicate-device-support-premarket-notification-510k-submission) 2. [2 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 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 5/5/2026 [Compare with another term](/compare?a=predicate-device) Learn in 60 seconds Card Lesson Quiz A legally marketed device used as the comparator in a 510(k) submission. - · Selecting an appropriate predicate is one of the most consequential decisions in a 510(k). - · An ill-chosen predicate can trigger a Not Substantially Equivalent (NSE) determination, requiring a De Novo or PMA pathway. Remember this Watch out: Choosing a predicate device with different indications for use than the new device can lead to a finding of "Not Substantially Equivalent." Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Substantial Equivalence(SE) ](/terms/substantial-equivalence) - [De Novo Classification Request(De Novo) ](/terms/de-novo) You may also need Auto-suggested from Regulatory and shared keywords. - [Special 510(k)(Special 510(k)) ](/terms/special-510k) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Benefit-Risk Determination ](/terms/benefit-risk) - [Class III Device ](/terms/class-iii) - [General Controls ](/terms/general-controls) - [Modular PMA ](/terms/pma-modular) [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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