In our due diligence work, we've reviewed hundreds of medical device companies seeking investment. And there's one issue that kills more deals than any technical or clinical concern: flawed 510(k) predicate strategy.
We call it the "Predicate Trap"—and it's far more common than most investors realize.
What Is the Predicate Trap?
The 510(k) pathway requires demonstrating that your device is "substantially equivalent" to a legally marketed predicate device. In theory, this is straightforward. In practice, predicate selection is an art—and getting it wrong can derail your entire regulatory strategy.
The Predicate Trap occurs when a company:
- Selects a predicate based on convenience rather than true equivalence
- Uses an outdated predicate that the FDA views as technologically obsolete
- Relies on a predicate with known safety issues or regulatory history
- Chooses a predicate cleared for a narrower indication than intended
- Builds an entire development program around a predicate that was never appropriate
Real-World Consequences
Case Study: The $8M Detour
A surgical device company raised Series A funding based on a 510(k) timeline of 12 months. Their predicate was a device cleared in 2008 with similar intended use but significantly different technology.
Six months into the FDA review, they received an Additional Information request questioning the predicate selection. The FDA recommended they either find a more appropriate predicate or pursue a De Novo pathway.
The resulting pivot added 18 months and $8M in additional development costs—nearly wiping out their runway and forcing a highly dilutive bridge round.
Red Flags We Look For
How to Avoid the Trap
1. Conduct a Thorough Predicate Landscape Analysis
Don't just find one predicate—map the entire landscape. Identify all potentially relevant predicates, analyze their clearance histories, and understand why each was or wasn't successful.
2. Engage FDA Early
Pre-Submission meetings are invaluable for validating predicate selection. The $5,000-10,000 cost is trivial compared to the risk of building a program on a flawed foundation.
3. Build Flexibility Into Your Strategy
Identify backup predicates and understand the implications of each pathway option. If your strategy depends entirely on one predicate being accepted, you're exposed.
4. Conduct Independent Regulatory Diligence
If you're an investor, don't rely solely on the company's regulatory consultants. Get independent verification of the predicate strategy from experts without conflicts of interest.
The Bottom Line
Predicate strategy is not a checkbox exercise—it's a critical strategic decision that shapes your entire development program. Companies that treat it with appropriate rigor will navigate the regulatory pathway efficiently. Those that don't will find themselves trapped.
References
- FDA. "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission." Draft Guidance, September 2023. fda.gov
- FDA. "How to Find and Effectively Use Predicate Devices." fda.gov
- FDA. "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications." fda.gov
- Covington & Burling LLP. "FDA Proposes Significant Shift to 510(k) Process in Draft Guidance on 'Best Practices' for 510(k) Predicate Selection." September 2023. cov.com
- Emergo by UL. "U.S. FDA Medical Device Predicate Selection for 510(k) Submissions." White Paper, November 2024. emergobyul.com
- Johner Institute. "Predicate device & substantial equivalence." February 2025. johner-institute.com
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