The 510(k), analyzed in seconds.

Every answer cites the FDA rule or the past clearance behind it. A qualified person reviews and signs before you file.

Predicate legally eligible

45,921 of 45,922

past clearances re-run · source

How often we are right

95.5% to 100%

on the 8 answers that have a right answer — 4 of them at 100%. The other 4 rank, flag or predict a range, and are measured in their own terms · source

The four things this analysis reads for — the more of them present, the stronger the equivalence argument it can make:

What the device is and does
Its indications for use
Technology, materials, energy source
A predicate or K-number, if you have one

Attach

Checking the analysis service before you run…

Already cleared something like it? Start from a K-number

Your draft and your caseload stay in this browser. Two services read your text to fill the fields and neither stores it; after a successful analysis the draft is deleted and only the extracted fields are kept. Nothing is filed without a qualified person’s signature. How your text is processed

What is different about it

It shows how often it is wrong — measured on past clearances, with the count it was measured on, beside every answer.
It traces recalls back through your predicate’s ancestry — a recalled ancestor shows up before you build on it.
It says so when the record is silent — an unsupported comparison is what draws FDA’s Additional Information letter.

What this does not do

It does not write your test reports, your protocols or your labeling, and it does not sign — a qualified person does (21 CFR 11.100).
Where your document leaves a fact open, it asks you one question instead of guessing.
It only knows what FDA has published. If FDA’s data is behind, the dossier says so, and by how many days.

Before launch: no consultant has filed from this yet. Every figure is measured on FDA’s own record, not on users. The first review sessions with consultants are next. What they find will be published on the changelog.