# HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

- Device class: 2; regulation: 21 CFR 882.4310; FDA's rule: 510(k) required
- FDA decisions: 65
- 510(k) review time 2021–2025: median 87 days (middle half 30–237)
- Recalls: 142 (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)
- 2015: 3
- 2016: 2
- 2017: 2
- 2018: 2
- 2019: 5
- 2021: 6
- 2022: 2
- 2023: 2
- 2025: 6
- 2026: 1

## Most-cited predicates
- K111520: Ipc Powerease System (2011), cited by 12
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (2008), cited by 11
- K943541: 75K Staight Drill (1995), cited by 7
- K113476: Anspach Dissection Tools (2011), cited by 6
- K123270: Powerease System (2013), cited by 4
- K062842: Twist Drill (2006), cited by 4
- K143540: Stryker MIS Attachments and Cutting Accessories (2015), cited by 3
- K161704: Phasor Drill (2016), cited by 3
- K922299: Zeppelin Motor Drill System (1992), cited by 3
- K032303: Stryker Consolidated Operating Room Equipment (Core) System (2004), cited by 3

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