Why we built this

510(k) research shouldn't take three days.

Regulatory affairs consultants and device founders were spending hours — sometimes days — on work that should take an afternoon. Searching across three FDA databases, cross-referencing PDFs, building comparison tables by hand.

The data was always public. The problem was that it was scattered, unstructured, and painful to work with. We built Predicase to change that — a single tool that does the searching, comparing, and organizing so consultants can focus on the judgment call, not the mechanics.

175,000+

FDA 510(k) clearances indexed — every one since 1976.

Daily sync

Data updated every day from openFDA. New clearances appear within 24 hours.

Built for RA

Designed around how regulatory consultants actually work — not how engineers imagine they do.

The company

Lumenthis Labs LLC

Lumenthis Labs is an independent software company incorporated in the United States. We build vertical tools for professionals doing compliance-heavy work in regulated industries — starting with medical devices.

We are a small, focused team. We ship quickly, obsess over data quality, and build for professionals who can't afford tools that cut corners. Predicase is our first product. More are in development.

We're independent and self-funded. No venture capital, no growth-at-all-costs mandate. Our incentive is simple: build something good enough that people pay for it and keep paying.

Our approach

Focused tools. No bloat.

We don't try to build everything. Predicase does one thing — 510(k) predicate research — and we intend for it to be the best tool available for that job. Every feature we ship is in service of that goal.

We talk to our users regularly. When a regulatory consultant tells us a workflow is wrong, we fix it. When an RA team asks for a feature, we build it if it makes the core job better. We don't build features for demo slides.

The regulatory data Predicase surfaces is public domain — it comes from the FDA and belongs to everyone. What we've built is the layer on top: the search engine, the comparison tools, the organization system, and the exports. That's where the work is.

What we stand for

A few things we won't compromise on.

Data accuracy

If the data is wrong, the tool is useless. We sync directly from openFDA daily and flag anything that looks anomalous. We'd rather surface nothing than surface something wrong.

No dark patterns

No fake urgency. No hidden cancellation flows. No confusing pricing. Cancel in two clicks. We want users who stay because Predicase is worth it — not because leaving is hard.

Honest limits

Predicase is a research tool, not a regulatory advisor. It does not tell you which predicate to pick. That judgment belongs to the professional using it. We're explicit about what the tool does and doesn't do.

Built for the people doing the actual work.

510(k) research shouldn't take three days.

Lumenthis Labs LLC

Focused tools. No bloat.

A few things we won't compromise on.

We read every email.

Everything you need for a 510(k) submission. Nothing you don't.