Free · no signup · public data
Four tools we use daily inside MedTek OS.
Built from FDA's own data. Same engines power Compass when you become a tenant. Use them as much as you want.
01
Predicate Finder
Search openFDA's 510(k) database for substantially equivalent predicates. Filter by class, browse the full clearance record, drop the K-number into Compass.
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02
Cost Calculator
FDA user fees plus realistic ranges for regulatory consulting, testing, and clinical work. FY2025 fee schedule, small-business discount applied automatically.
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03
Timeline Estimator
Phase-by-phase timeline for 510(k), De Novo, PMA, IDE, and Pre-Sub. Built from FDA Performance Reports. See exactly where your weeks go.
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04
PCCP Generator
Draft a Predetermined Change Control Plan for an AI/ML medical device, structured per FDA's August 2024 guidance. Three sections, ready to customize.
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Want all four inside one workspace?
Compass runs these against your evidence, not just the public data.
With a tenant, the predicate finder reasons over your prior submissions, the cost calculator pulls your real consulting rates, the timeline estimator factors in your team size and historical FDA velocity, and the PCCP generator writes acceptance criteria backed by your real validation distributions.
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