# QPF: Pediatric Autism Spectrum Disorder Diagnosis Aid

- Device class: 2; regulation: 21 CFR 882.1491; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 143 days (middle half 131–152)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2021: 1
- 2022: 1
- 2023: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- DEN200069: Cognoa ASD Diagnosis Aid (2021), cited by 2
- K213882: EarliPoint System (2022), cited by 1
- K243891: EarliPoint System (2025), cited by 1
- K230337: EarliPoint (2023), cited by 1

Source page: https://510kreport.com/product-code/QPF
Data by year (CSV): https://510kreport.com/product-code/QPF.csv