Built specifically for 510(k) predicate research — not a generic database with a new coat of paint.
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.
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.
Every record links directly to the FDA's official decision summary on accessdata.fda.gov — one click, no manual searching required.
Every predicate page surfaces other cleared devices with the same product code — instant additional candidates without launching a new search.
Click any K-number to copy it to your clipboard instantly. Small thing — saves you every time you need to paste it into an email or submission document.
Bookmark any search query and filter combination. Your saved searches are always one click away — pick up exactly where you left off, every session.
K-numbers and product codes are always rendered in monospace. Scanning a list of clearances is faster when the data looks like data.
Predicase is fully responsive. Search and review clearances on a laptop, tablet, or phone — the layout adapts cleanly to your screen size.
Predicase helps you find and compare predicates. The regulatory judgment — whether your device is substantially equivalent — is yours. We give you the data; you make the call.
If you're a device founder without regulatory experience, Predicase makes your conversations with your RA consultant faster and better-informed. It doesn't replace those conversations.
Predicase is scoped to 510(k) clearances only. PMA approvals and De Novo grants are different regulatory pathways and are not in scope.