FDA 510(k) Submission Platform

Automate your 510(k) submissions with AI.

Pathfinder Med transforms weeks of regulatory documentation into hours. Upload your device information, let AI draft the package, and export a submission-ready eSTAR bundle.

Get StartedSee how it works

Process

How it works

01

Upload device info

Enter your device classification, intended use, and predicate device details through our guided intake wizard.

02

AI generates documents

Our models draft your 510(k) sections — substantial equivalence analysis, performance testing summaries, and more — in minutes.

03

Export eSTAR package

Download a submission-ready eSTAR package formatted to FDA eCopy specifications, ready to upload to CDRH.

Powered by MiroFish

AI simulation & scenario modeling.

MiroFish runs thousands of regulatory scenarios against your submission before you file — surfacing edge cases, predicate mismatches, and likely reviewer questions so you can address them proactively.

  • Predicate equivalence stress-testing
  • Risk-based document gap analysis
  • Reviewer question simulation
  • eSTAR completeness validation

~87%

first-cycle clearance rate with simulation pre-check

6×

faster than traditional manual prep

Ready to accelerate your 510(k)?

Start your first submission today. No prior regulatory experience required.

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