Predicate device search, ranked by substantial equivalence.
The right predicate is the foundation of a 510(k). REGARA finds substantially equivalent devices by indication and technology, then builds the comparison your reviewer will scrutinize.
A predicate device is a legally marketed device to which a new device claims substantial equivalence in a 510(k). Choosing the right predicate is the single most consequential early decision in a device submission — it defines the comparison the FDA will hold you to and the performance data you’ll need.
Traditional predicate research means combing the FDA’s 510(k) database by hand, reading clearance summaries, and judging equivalence device by device. It’s slow, and a weak or outdated predicate can sink an otherwise strong submission — roughly a fifth of clearances still lean on predicates over a decade old.
REGARA searches semantically across cleared devices, ranks candidates by indication, technology, and substantial-equivalence proximity, and assembles the side-by-side comparison table — every row anchored to the source clearance.
- 01Semantic candidate search
Search cleared devices by what they actually do — indication and technological characteristics — not just product codes and keywords.
- 02SE-proximity ranking
Rank candidate predicates by how closely they map to your device on the dimensions the FDA weighs for substantial equivalence.
- 03Comparison table builder
Generate the side-by-side SE comparison automatically, with every attribute traced to the predicate’s clearance record.
- 04Predicate-risk flags
Surface warning signs — age, rescinded clearances, or recall history — before you commit to a predicate.
Why the predicate decision is make-or-break.
It sets the comparison.
Your predicate defines what the FDA compares you against. A poor choice forces an uphill equivalence argument from day one.
Predicate drift.
Leaning on obsolete predicates invites scrutiny. REGARA favors current, defensible clearances and documents why.
Traceable rows.
Every line of the comparison table links to the source clearance, so your rationale withstands review.
- QWhat is a predicate device?
A predicate device is a legally marketed device that a new device compares itself to in a 510(k) to establish substantial equivalence. The predicate must have the same intended use and comparable technological characteristics.
- QHow do I find the right predicate device?
Strong predicate selection matches intended use and technology, favors current clearances, and avoids devices with recall or rescission history. REGARA searches semantically across cleared devices and ranks candidates by substantial-equivalence proximity so you can compare the best options quickly.
- QCan I use more than one predicate?
Yes. A 510(k) may cite a primary predicate and one or more reference devices to support specific technological characteristics, provided the overall comparison still establishes substantial equivalence. REGARA helps structure multi-predicate comparisons cleanly.
- QWhy does predicate age matter?
Older predicates may reflect outdated technology or superseded standards, which can weaken an equivalence argument and draw reviewer questions. REGARA flags predicate age and surfaces more current alternatives where they exist.
Explore related pathways and research.
Draft and defend a substantial-equivalence submission with predicate evidence built in.
CapabilityA daily-indexed atlas of FDA, EMA, and PMDA guidance mapped to your submission.
White paperHow RTA gatekeeping and predicate drift stall device innovation and global access.
Find your strongest predicate.
Bring your device concept. In a 30-minute working session we’ll surface ranked predicates and build a comparison against your indication.