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.
Before committing to a predicate, check its post-market history. Pro users can search 1.18M+ MAUDE adverse event reports by product code — see malfunctions, injuries, and deaths reported for that device type.
Intelligence users also get FDA warning letter history — see if the applicant has received CDRH enforcement action, what FDA cited them for, and whether the letter is still open.
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 shortlists to named projects — one per client engagement. Export the full project as PDF or CSV. Your work is always there when you come back.