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Why this term here: The pathway itself. Focus on what a 510(k) is and, just as importantly, what it is not (it is not an approval). ](/terms/510k?from=510k-fundamentals)Mark done 2. 2 [ Regulatory ## Predicate Device A legally marketed device used as the comparator in a 510(k) submission. Why this term here: The whole submission hinges on this choice. Focus on how to pick a predicate that supports your claims without expanding indications. ](/terms/predicate-device?from=510k-fundamentals)Mark done 3. 3 [ Regulatory ## Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. Why this term here: The legal standard FDA applies. Focus on the decision tree of intended use, technological characteristics, and safety/effectiveness. ](/terms/substantial-equivalence?from=510k-fundamentals)Mark done 4. 4 [ Regulatory ## Intended Use The objective intent of the manufacturer regarding the use of the device. Why this term here: The regulatory anchor for your device. Focus on why this differs from marketing language and why edits later are painful. ](/terms/intended-use?from=510k-fundamentals)Mark done 5. 5 [ Regulatory ## Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. Why this term here: The specific patient population and condition. Focus on the difference between intended use and indications, and how each is worded. ](/terms/indications-for-use?from=510k-fundamentals)Mark done 6. 6 [ Regulatory ## Refuse to Accept(RTA) FDA administrative decision that a submission is incomplete and won't be substantively reviewed. Why this term here: The first hurdle after submission. Focus on the checklist items that most commonly trigger a hold. ](/terms/rta?from=510k-fundamentals)Mark done 7. 7 [ Regulatory ## De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. Why this term here: The alternative when there is no predicate. Focus on when De Novo beats forcing a weak 510(k). ](/terms/de-novo?from=510k-fundamentals)Mark done Finished the path? Test yourself with a quiz tailored to these 7 terms. [Take the 510(k) Fundamentals quiz](/quiz?path=510k-fundamentals) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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