# K213882: EarliPoint System

- Pathway: 510(k) (Traditional)
- Applicant: Earlitec Diagnostics, Inc.
- Decided: Jun 8, 2022 after 177 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
Longest line of descent: 1 generation back to DEN200069 (2021). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200069: Cognoa ASD Diagnosis Aid, Cognoa, Inc. (2021) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The EarliPoint System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) for patients ages 16 months through 30 months.

Source page: https://510kreport.com/device/K213882
Methodology: https://510kreport.com/methodology