# HJT: Haploscope

- Device class: 1; regulation: 21 CFR 886.1340; FDA's rule: 510(k) exempt
- FDA decisions: 2
- 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)
- 2001: 2

## Most-cited predicates
- K012530: AA-1 System (2001), cited by 1

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