510(k) Report

FDA applicant

Cognoa, Inc.

Palo Alto, CA2 decisions2021–20250 recalls

FDA records 2 decisions for Cognoa, Inc. (Palo Alto, CA) from 2021 to 2025: 1 510(k) clearance and 1 De Novo grant. All are in product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Cognoa, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12025: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Cognoa, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cognoa, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QPFPediatric Autism Spectrum Disorder Diagnosis Aid2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN200069Cognoa ASD Diagnosis AidCognoa, Inc. · 20212cite it

What has FDA decided for it lately?

  • K243558Canvas DxCognoa, Inc. · 2025
  • DEN200069Cognoa ASD Diagnosis AidCognoa, Inc. · 2021

All 2 as Cognoa, Inc. →