Medical Device Manufacturer · US , Menlo Park , CA

Subtle Medical, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2018

Total

Cleared

Denied

Subtle Medical, Inc. has 9 FDA 510(k) cleared medical devices. Based in Menlo Park, US.

Latest FDA clearance: Feb 2025. Active since 2018. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Subtle Medical, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Enzyme Corporation as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Subtle Medical, Inc.

9 devices

1-9 of 9

Regulatory Intelligence

PCCP authorized FDA software change control pathway

Regulatory consultant 510(k) submission support ecosystem

Enzyme Corporation

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 05, 2026

Subtle Medical, Inc. - FDA 510(k) Cleared Devices

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