Predicase

What it solves

Finding valid predicates for a 510(k) submission means manually searching FDA databases, cross-referencing device codes, and digging through clearance letters one by one. For a regulatory consultant managing multiple clients, that's days of work per submission.

What it is

Predicase is a 510(k) predicate research tool that searches 175,000+ FDA clearances, surfaces predicate chains, and lets you compare devices side by side. You can export submission-ready PDFs without touching the FDA website.

Built for

• — Regulatory affairs consultants
• — Medical device founders
• — RA/QA teams preparing 510(k) submissions

What's included

Other products from Lumenthis Labs