# HAO: Instrument, Surgical, Non-Powered

- Device class: 1; regulation: 21 CFR 882.4535; FDA's rule: 510(k) exempt
- FDA decisions: 34
- 510(k) review time 2021–2025: median 161 days (middle half 161–161)
- Recalls: 2 (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)
- 1986: 4
- 1987: 1
- 1988: 3
- 1989: 1
- 1990: 1
- 1991: 2
- 1992: 1
- 1994: 6
- 1995: 2
- 2022: 1

## Most-cited predicates
- K801760: Field-Lee Brain Biopsy Needle (1980), cited by 2
- K940973: Mullan Ganglion Microcompression Set (1995), cited by 1

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