# HBG: Drills, Burrs, Trephines & Accessories (Manual)

- Device class: 2; regulation: 21 CFR 882.4300; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 86 days (middle half 86–86)
- Recalls: 39 (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)
- 1990: 2
- 1991: 1
- 1993: 1
- 1996: 1
- 2002: 2
- 2013: 1
- 2015: 1
- 2016: 1
- 2017: 2
- 2025: 1

## Most-cited predicates
- K122456: Mrii Crainial Drill (2013), cited by 4
- K961113: CNS Interchangeable Bit Cranial Drill (1996), cited by 3
- K162884: SpineGuard DSG Zavation Screw System (2017), cited by 1
- K904283: PS Medical Cranial Hand Drill (1990), cited by 1
- K022370: Framelock; Framelock Accessories (2002), cited by 1
- K022712: Hand Drill, Model 11-9901-7 (2002), cited by 1
- K862160: Camino Hand Drill - Model 030 (1986), cited by 1
- K160129: MRII Cranial Drill and Accessories (2016), cited by 1
- K915546: PS Medical Ventriculostomy Kit (1991), cited by 1
- K151536: SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (2015), cited by 1

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