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For founders and CEOs

Stop figuring out FDA alone.

Regulatory, quality and documentation, guided in one place, so your startup gets the expertise it needs without building a full regulatory and quality team.

Guided, not outsourced.

Book a demo Try the free predicate search

The hard part isn't the device.

It's everything FDA needs to see around it, usually learned the expensive way.

No regulatory team

Design controls, risk files and a quality system usually take specialists a startup can't hire yet.

An unclear path

510(k), De Novo, PMA or exempt? The answer depends on your class and your predicate, and it changes what you build.

Costly mistakes

The wrong predicate or a gap in the record can cost you months. Most of those gaps are visible early, if you know where to look.

Allele guides each step.

You stay in charge of the decisions. Allele does the research, drafts the first version and shows its sources.

  1. Step 1

    Device profile

    Set the class: it drives everything

  2. Step 2

    Predicate search

    Screened on intended use, recall-flagged

  3. Step 3

    Confirm pathway + Pre-Sub

    510(k) chosen on the predicate; questions to FDA

  4. Step 4

    Records

    Requirements · Risk · Usability · tests

  5. Step 5

    Compile the 510(k) package

    Pulled from your records

  6. Step 6

    You file · we track

    CDRH Portal · ~90-day clock

510(k) user fee $28,653, or $7,163 for a small businessFDA review goal: 90 FDA days. FY2027 FDA figures, a planning estimate: confirm current fees with FDA.

See every step in detail

What you get, from a founder's seat.

Find your predicate.

Start from the right cleared device, not a guess. Every candidate links to FDA's clearance summary, so you can read why it matched.

Know your path.

Class-aware pathway strategy for 510(k), De Novo, PMA or exempt, so you budget for the route you're actually on.

Prove every answer.

AI you can check. Each AI answer shows its source and stays unverified until you accept it, so you understand your own submission.

One connected workspace.

Design controls, risk, quality records and submission readiness in one place, instead of spreadsheets and shared drives.

Why Allele exists

"At Stryker and Medline, design records were logged by hand in spreadsheets, design controls took a team, and regulatory strategy took an RA team weeks. Allele brings that expertise to startups that can't afford a regulatory department."

Built by a device-industry regulatory practitioner.

Allele isn't a generic AI wrapper. It's built by a medtech practitioner who has been through the predicate and submission process many times (at a device startup and two of the largest device companies in the world), with a biomedical-engineering background behind the science and the standards.

  • Hands-on submission experience across many devices, at startup and enterprise scale.
  • Content grounded in real FDA research and verified as it's built.
  • Honest about what's still draft: where content is best-effort, the tool says so.
  • Founder-market fit: built by the buyer it's built for.

What the logo means

An allele is a version of a known gene. A new device is a version of a known, cleared device.

  • The blue dots are cleared devices already on the market.
  • The hollow dot is your predicate: the cleared device you measure against.
  • The coral dot is your new device.
  • The coral line is the substantial-equivalence link you have to prove.

Book a demo

Tell us what you're building. We'll walk through a predicate search and pathway plan on a device like yours.

Or write to katie.j.suarez@me.com

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