# Cognoa, Inc.

- Location (FDA's records): Palo Alto, CA
- FDA decisions: 2 (2021–2025): 1 510(k) clearance and 1 De Novo grant
- Product codes: QPF (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Earlitec Diagnostics, Inc.: 1 (https://510kreport.com/company/earlitec-diagnostics)

## Its most-cited devices
- DEN200069: Cognoa ASD Diagnosis Aid (2021), cited by 2

## Recent decisions
- K243558: Canvas Dx (Apr 11, 2025)
- DEN200069: Cognoa ASD Diagnosis Aid (Jun 2, 2021)

Source page: https://510kreport.com/company/cognoa