Built specifically for 510(k) predicate research — not a generic database with a new coat of paint.
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Discovery, transparent AI-ranking, ongoing health monitoring, and SE rationale drafting — all built around the device description you save to a project. See the full workspace →
Once your device description is saved, Predicase searches the full 510(k) corpus for similar devices automatically — candidates you can add to your project in one click, before you've run a single keyword search.
Every scored predicate shows its work — semantic similarity, product code match, recency, and precedent strength, each broken out individually. Not a single opaque number you're asked to trust.
Generate a draft substantial equivalence argument comparing your device to any saved predicate — intended use and technological characteristics argued separately, flagged automatically if your description changes after the draft was made.
Watch any predicate and get one combined email if it gets a new MAUDE adverse event report, an FDA recall, or a CDRH warning letter — checked daily, so a predicate's safety profile can't shift underneath your strategy unnoticed.
Search by device name, K-number, product code, applicant, or intended use text. Results ranked by relevance, updated daily from openFDA. Filter by device class, product code, applicant, decision type, and clearance year — all live, no page reloads.
Compare up to 3 predicates in a structured column view. Every field is lined up — device class, product code, clearance type, review panel, regulation number. Cells that differ are automatically marked with a gold stripe.
Organize saved predicates by client engagement or submission. Rename, reorder, and delete projects at any time. Export an entire project shortlist as PDF or CSV with one click.
Generate a structured predicate summary PDF formatted to drop into Section 4 of an eSTAR. Export comparison tables as CSV for further analysis. Pro users get branded exports with their firm name on every page.
Narrow results by device class (I, II, III), product code, applicant name, decision type, and clearance year range. Save searches and come back to them — your most recent searches are always one click away.
The FDA 510(k) database is pulled and indexed every day at 6am UTC. New clearances appear in Predicase within 24 hours — device class and regulation number are automatically backfilled after each sync.
Explore 175,000+ clearances by medical specialty instead of searching for a specific device — Cardiovascular, Orthopedic, Anesthesiology, and 13 others. Each panel shows regulation and product code counts, a device class breakdown, and the most common product codes by volume.
Pro adds MAUDE adverse event monitoring and predicate health monitoring — so you can check a device's post-market safety history before building your submission around it, and keep watching after.
Search FDA's MAUDE database of 10M+ medical device adverse event reports directly from Predicase. See malfunction, injury, and death reports for any device — filtered by product code, manufacturer, or K-number. Know the post-market safety record of a predicate before you commit to it.
Every predicate detail page shows a summary of MAUDE reports for that device — total reports, event types, and trend over the last 3 years. No separate search required.
Narrow MAUDE results by event type — malfunction, injury, or death — and by manufacturer. Identify whether adverse events are isolated incidents or a pattern that could affect your predicate strategy.
Intelligence adds warning letter history, predicate chain visualization, and the full AI Predicate Workspace — for consultants who need to know everything about a predicate before committing to a submission strategy.
Search and monitor FDA warning letters by manufacturer, product type, and violation category. See whether a predicate's applicant has received warning letters — and what FDA cited them for. Understand the enforcement history before you cite their device in your submission.
Every 510(k) was cleared based on a predicate — which itself was cleared based on an earlier predicate. Trace that lineage visually, generation by generation. See how far back the chain goes and identify any weak links before FDA does.
Export the full predicate chain as a structured PDF — every generation, every K-number, every clearance date. Drop it directly into your submission documentation to show the complete lineage of your chosen predicate.
Every clearance includes fields you'd otherwise have to look up across multiple FDA databases.
Class I, II, or III — backfilled from the FDA classification database for all 175,000+ records so you always know the risk classification.
CFR regulation number mapped from the product code — so you know exactly which 21 CFR part applies without opening a separate database.
The FDA advisory committee that reviewed the submission — Cardiovascular, Orthopedic, General Surgery, and 15 others — displayed on every record.
Traditional, Abbreviated, or Special — shows the exact review pathway used for this submission. Useful for understanding the precedent you're setting.
Direct download link to the FDA-hosted summary PDF when available — no searching on accessdata.fda.gov. One click from the predicate record.
Every predicate page automatically surfaces other cleared devices with the same product code — instant additional predicate candidates without a new search.
The AI Predicate Workspace helps you find, score, and draft — but the regulatory judgment, whether your device is substantially equivalent, is always yours to make and defend. Every score is shown with its breakdown and every draft is meant to be reviewed and edited, not filed as-is.
Predicase is scoped to 510(k) clearances only. PMA approvals and De Novo grants are different regulatory pathways and are not in scope.