# DEN200069: Cognoa ASD Diagnosis Aid

- Pathway: De Novo (Direct)
- Applicant: Cognoa, Inc.
- Decided: Jun 2, 2021 after 211 days
- Product code: QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid)
- Device class: 2
- Regulation: 21 CFR 882.1491
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K213882: EarliPoint System (2022), 3 descendants of its own
- K230337: EarliPoint (2023), 2 descendants of its own
- K243891: EarliPoint System (2025), 1 descendant of its own
- K253442: EarliPoint Assessment (2026), 0 descendants of its own
- K243558: Canvas Dx (2025), 0 descendants of its own

## Indications for use
The Cognoa ASD Diagnosis Aid is intended for use by healthcare providers as an aid in the diagnosis of Autism Spectrum Disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.

Source page: https://510kreport.com/device/DEN200069
Methodology: https://510kreport.com/methodology