Three steps from first search to submission-ready PDF. Designed for the way regulatory consultants actually work.
Type a device name, K-number, product code, or paste in an intended use statement. Predicase searches the full FDA 510(k) database — updated daily from openFDA — and returns ranked results in under a second.
Filter by device class, product code, applicant, decision type, and clearance year. Every filter combination updates results live — no page reloads.
Add up to three predicates to your comparison view. Predicase lines up every field — product code, device class, clearance type, review panel, regulation number — so differences are immediately visible.
Cells that differ across your candidates are marked with a gold stripe. No manual spreadsheet. No PDF cross-referencing.
Generate a submission-ready PDF summary of your selected predicate — formatted to drop directly into Section 4 of an eSTAR. Pro users get branded exports with their firm's name on every page.
Save your shortlist to a named project per client engagement. Come back anytime. Your work is always there.
Device class, regulation number, review panel, clearance type, summary PDF links — all in one place.
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