QPF
6 FDA 510(k) clearances · Product code
155 daysmedian time to decision
211 days90th percentile
6clearances measured
FDA profile
- Official device name
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1491
- Medical specialty
- Neurology
- FDA definition
- A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EarliPoint Assessment (K253442) | Earlitec Diagnostics | 2026-03-05 |
| Canvas Dx (K243558) | Cognoa, Inc. | 2025-04-11 |
| EarliPoint System (K243891) | Earlitec Diagnostics | 2025-03-26 |
| EarliPoint (K230337) | Earlitec Diagnostics, Inc. | 2023-06-29 |
| EarliPoint System (K213882) | Earlitec Diagnostics, Inc. | 2022-06-08 |
| Cognoa ASD Diagnosis Aid (DEN200069) | Cognoa, Inc. | 2021-06-02 |
Track QPF automatically
Every clearance here is in the API, with alerts when new ones post.