# HST: Apparatus, Traction, Non-Powered

- Device class: 1; regulation: 21 CFR 888.5850; FDA's rule: 510(k) exempt
- FDA decisions: 38
- Recalls: 7 (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)
- 1980: 3
- 1981: 3
- 1982: 6
- 1983: 3
- 1984: 3
- 1986: 4
- 1987: 4
- 1999: 1
- 2011: 1
- 2016: 1

## Most-cited predicates
- K110858: LO-Bak Trax (2011), cited by 1

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