If you’re building a medical device, a diagnostic, or most digital health tools, the FDA 510(k) pathway is very likely the road you’re on — whether you’ve named it yet or not. It’s also the specific pathway this competition is built around: our eligibility rules exclude pharmaceuticals and Class III devices precisely because they follow a different, much longer process (Premarket Approval, or PMA). Understanding why 510(k) is different is worth ten minutes before you write a single slide.
What 510(k) actually is
Section 510(k) of the Food, Drug, and Cosmetic Act requires device makers to notify the FDA at least 90 days before marketing a device — and to show that it’s substantially equivalent to a device already legally on the market. That reference device is called a predicate.
You are not proving your device is safe and effective from scratch. You’re proving it’s as safe and effective as something already cleared. That distinction is the entire reason this pathway is faster and cheaper than PMA.
Who this applies to
510(k) covers most Class I and Class II medical devices — the two lower-risk tiers. Class I devices (think bandages, exam gloves) are mostly exempt from 510(k) entirely. Class II devices — infusion pumps, many diagnostic imaging tools, a large share of digital health software — are exactly where most first-time medical device founders land, and exactly where this competition is scoped.
Class III devices (implantable defibrillators, heart valves) and pharmaceuticals go through PMA or the drug approval process instead — longer, more expensive, and outside what this Expo evaluates.
The predicate device is everything
Before you do anything else, identify your predicate. The FDA’s own database — 510(k) Premarket Notification search — lets you search cleared devices by product code, applicant, or device name. A strong predicate:
- Shares your intended use
- Shares your basic technological characteristics
- Was cleared recently enough that its clearance is still a credible reference point
Applicants who’ve already identified a predicate are more competitive in our review — it’s one of the clearest signals that an idea has a real, short path to market rather than an open-ended research question.
Why this shapes your pitch deck
Two slides in the Sequoia format map directly onto this pathway:
- “Why now” is a stronger slide when you can point to a specific predicate and a specific gap it leaves.
- “Speed to market” — one of our evaluation committee’s explicit criteria — is largely a function of how clean your 510(k) path is.
A device with a strong predicate and a clear technological match isn’t just easier to get through the FDA. It’s easier to explain, easier to fund, and easier to license.
Where to go deeper
The FDA publishes its own overview at fda.gov/510k, including the full submission checklist. If you’re at the point of preparing an actual submission, working with a regulatory consultant or your institution’s technology transfer office is worth the cost — but understanding the shape of the pathway costs nothing, and it’s the difference between a pitch that sounds informed and one that doesn’t.