175,000+ FDA 510(k) clearances · indexed daily

Find your 510(k) predicate. Build the submission. Move on.

Built for the people behind every 510(k) — consultants, founders, and in-house RA teams.

  • Search 175,000+ 510(k) clearances by name, K-number, product code, or intended use
  • Compare predicates side by side with differences highlighted automatically
  • Organize shortlists per submission across client engagements
  • Discover and score predicates automatically with a transparent AI-ranking breakdown
  • Export submission-ready PDFs and check adverse event history — all before you file
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Built for the people who do this for a living
Independent regulatory consultants Device startup founders RA/QA at small manufacturers Submission-prep CROs
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AI Predicate Workspace

A score you can defend, not just a number you're told to trust.

Describe your device once. Predicase finds candidate predicates, scores them with a visible breakdown, and drafts your SE rationale — all from the same project.

A black-box AI score
"87"

A single number, no breakdown. You can't tell a reviewer — or yourself — why it's an 87 and not a 60.

Predicase's AI-ranking score
87

Similarity 39/45 · product code match 25/25 · recency 12/15 · cited as a predicate 4 times. Every point traces back to something real.

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A 510(k) workspace, not another database

Built around the three things you actually do all day.

01 / How it works

Search, compare, export — in 20 minutes.

Three steps from first search to submission-ready PDF — designed for the way regulatory consultants actually work.

See the workflow → 02 / Features

Everything that should be in one tool, finally is.

Full-text search, side-by-side comparison with diff highlighting, AI predicate discovery and scoring, MAUDE adverse event and predicate health monitoring.

Browse features → 03 / Pricing

Three plans for solo consultants and founders.

Starter $199 · Pro $399 · Intelligence $699 · Enterprise on request. 14-day free trial on Starter.

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Everything you need for a 510(k) submission. Nothing you don't.

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