Medical Device Manufacturer · US , Palo Alto , CA

Cognoa, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2021

Total

Cleared

Denied

Cognoa, Inc. has 1 FDA 510(k) cleared medical devices. Based in Palo Alto, US.

Latest FDA clearance: Apr 2025. Active since 2021. Primary specialty: Neurology.

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

510(k) submissions have been managed by RQM+ 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 - Cognoa, Inc.

2 devices

1-2 of 2

Not Cleared Jun 02, 2021

Cognoa ASD Diagnosis Aid

DEN200069 · QPF

Neurology · 211d

Regulatory Intelligence

PCCP authorized FDA software change control pathway

Regulatory consultant 510(k) submission support ecosystem

RQM+

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 02, 2026

Cognoa, Inc. - FDA 510(k) Cleared Devices

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