# HQO: Unit, Cautery, Thermal, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.4115; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1981: 1
- 1985: 2
- 1988: 1
- 1990: 1
- 1994: 1
- 1996: 1
- 1997: 1
- 2000: 2
- 2004: 1
- 2007: 1

## Most-cited predicates
- K043155: Starion Universal Power Supply (Ups) (2004), cited by 2
- K971538: Mentor Gemini Hemostatic Eraser (1997), cited by 1
- K874367: Various Cardiac Cryoprobes Having Dia. & Cos. Diff (1988), cited by 1
- K000893: AC Powered Thermal Cautery Unit (2000), cited by 1
- K810017: Microsurg Cautery (1981), cited by 1
- K962135: D.O.R.C. Microdiathermy System (1996), cited by 1

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