# HQP: Unit, Cautery, Thermal, Battery-Powered

- Device class: 2; regulation: 21 CFR 886.4115; FDA's rule: 510(k) required
- FDA decisions: 24
- 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)
- 1984: 4
- 1988: 1
- 1994: 1
- 1995: 5
- 1999: 1
- 2000: 2
- 2004: 1
- 2007: 1
- 2009: 1
- 2012: 1

## Most-cited predicates
- K990728: Thermal Cautery Device, Forceps (1999), cited by 2
- K945763: Low Temperature Cautery Elongated Fine Tip (1995), cited by 2
- K945762: Low Temperature Cautery Fine Tip, Adjustable (1995), cited by 2
- K023506: Surgical Medical Device Cautery (2004), cited by 2
- K121441: Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip) (2012), cited by 1
- K945761: Low Temperature Cautery Fine Tip, Adjustable, Replaceable Tip (1995), cited by 1
- K945493: Ophthalmic Cautery (1995), cited by 1
- K002547: Starion Instruments Power Point Cautery Grasper/Dissector (2000), cited by 1

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