MedTech Terms
    The authoritative reference
    Compare

    Two terms, side by side

    Pick any two terms to see definitions, context, pitfalls, and sources in parallel.

    Regulatory

    510(k) Premarket Notification(510(k))

    In one line
    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).
    Why it matters
    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.
    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.
    Open full page
    Regulatory

    De Novo Classification Request(De Novo)

    In one line
    Pathway to classify novel low- to moderate-risk devices that lack a predicate.
    Definition
    The De Novo classification process provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide a reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
    Why it matters
    Granting a De Novo creates a new device classification and can serve as a predicate for future 510(k) submissions, shaping the regulatory framework for an entire device category.
    Open full page

    Why compare MedTech terms side by side?

    MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

    Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

    Common comparison patterns

    How to use this tool

    Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

    MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.