Now in early access

Figure out your FDA pathway.
Without the confusion.

FDA classification is complex, expensive to get wrong, and opaque. We walk you through it in plain English — know your 510(k), De Novo, or PMA before you spend months figuring it out.

Or try the classifier free — no signup needed

THE FIRST-TIMER PENALTY

Experience is the variable.

We analyzed every 510(k) the FDA has ever cleared — all 175,607 of them. Companies filing for the first time wait months longer than companies that have done it before, and almost the entire gap is paid on that first submission. Filing your tenth is barely faster than filing your second.

177days
From FDA receipt to decision, first-time filers: +54days
Longer than repeat filers wait for a decision: 44%
Of first-time submissions take more than 200 days: 33%
Of all 510(k)s are refused acceptance before review begins

Our analysis of the openFDA 510(k) dataset, July 2026: 881 first-time filers against 4,156 repeat filers, as median calendar days from receipt to decision — elapsed time, which includes applicant response, not FDA's internal review clock. Refuse to Accept rate per published CDRH analyses. These figures describe the industry, not results from using Medheron.

That gap is what we're building to close.

THE WORKSPACE

Everything between concept and clearance

Pathway in minutes

Describe your device and get the right pathway — 510(k), De Novo, or PMA — with the product code and CFR citation. No consultant, no weeks of research.

Predicate intelligence

Search the FDA 510(k) database and surface the strongest predicate devices for your substantial equivalence argument — instantly.

Try now

AI-drafted sections

Generate first drafts of device description, substantial equivalence, and labeling from your inputs. You stay in control; we do the heavy lifting.

Generated checklists

Every required section for your pathway, auto-generated and tracked to completion. Never guess what the FDA expects again.

Response tracking

Upload FDA correspondence, track deficiency deadlines, and keep your whole team on the same timeline from submission through clearance.

Audit-ready

Full version history and change logs on every document — built for your QMS and quality system compliance from day one.

Four steps from idea to cleared.

Classify

Describe your device and answer a few plain-language questions. We map it to an FDA product code and risk class.

Pathway

Get your recommended regulatory route with fees, typical timelines, and matching predicate devices.

Draft

AI generates first drafts of your required sections. Your team reviews, refines, and uploads supporting evidence.

Submit

Build the package, submit to the FDA, and track every response and deadline in one place.

Submit with confidence.

Start your first submission free. No credit card required.

Figure out your FDA pathway. Without the confusion.