# HBF: Drills, Burrs, Trephines & Accessories (Compound, Powered)

- Device class: 2; regulation: 21 CFR 882.4305; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 280 days (middle half 272–288)
- Recalls: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1998: 1
- 2003: 1
- 2007: 1
- 2008: 3
- 2012: 1
- 2015: 1
- 2019: 1
- 2022: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K071931: Codman Disposable Perforator, Model (S) 26-1222, 26-1223 (2007), cited by 5
- K892866: Automatic Cranial Drill (Perforator) (1989), cited by 4
- K833266: Acra-Cut (1983), cited by 4
- K791101: Disposable Perforators, Jacobs, Hudson (1979), cited by 4
- K933894: Disposable Perforator (1993), cited by 3
- K231403: evoDrill Cranial Perforator (2024), cited by 2
- K082010: Stryker Disposable Cranial Perforator Bit (2008), cited by 1
- K982991: Anspach Access Cranial Perforator (1998), cited by 1

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