# K243891: EarliPoint System

- Pathway: 510(k) (Special)
- Applicant: Earlitec Diagnostics
- Decided: Mar 26, 2025 after 98 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: 3 generations back to DEN200069 (2021). 3 ancestors in all.
1 later device descends 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)
- K230337: EarliPoint, Earlitec Diagnostics, Inc. (2023) Summary page 5.

## Most influential descendants
- K253442: EarliPoint Assessment (2026), 0 descendants of its own

## Indications for use
The EarliPoint System device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months, who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.

Source page: https://510kreport.com/device/K243891
Methodology: https://510kreport.com/methodology