Navigating the 510(k) Pathway
Your expert guide to identifying the right predicate device for a streamlined FDA submission.
What is a Predicate Device?
A predicate device is a legally marketed U.S. device to which a new device is compared to establish "Substantial Equivalence." This is the cornerstone of a successful 510(k) submission, proving your device is as safe and effective as one already cleared by the FDA.
Substantial equivalence is determined by two critical factors:
Same Intended Use
The new device must have the same purpose and be used in the same way as the predicate device.
Similar Technological Characteristics
The device's technology, materials, and design must be the same, or any differences must not raise new safety or effectiveness concerns.
Predicate Strength is Key
A strong, well-justified predicate is the leading indicator of a successful 510(k) clearance.
The Predicate Search & Submission Pathway
Step 1: Begin Your Search in FDA Databases
Utilize the 510(k) Premarket Notification and De Novo Classification databases.
Step 2: Analyze Potential Predicates
Evaluate against key criteria to find the best fit.
YES
Proceed with 510(k) Submission
Build your submission around the chosen predicate to demonstrate substantial equivalence.
NO
Consider De Novo Pathway
For novel, low-to-moderate risk devices with no existing predicate.
Deep Dive: How to Analyze Predicates
When examining a potential predicate's 510(k) summary, focus on these four critical areas to ensure the strongest possible comparison.
Intended Use
This is the most critical factor. Is the intended use identical? Even small differences can disqualify a predicate.
Tech Characteristics
Compare design, materials, energy sources, and mechanism of action. You must justify all differences.
Performance Data
Review the required testing (bench, animal, clinical). This provides a roadmap for your own validation efforts.
Clearance Date
The FDA prefers more recent predicates that reflect current technology and standards. Avoid very old predicates if possible.