# HBC: Motor, Drill, Electric

- Device class: 2; regulation: 21 CFR 882.4360; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 359 days (middle half 342–362)
- Recalls: 21 (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)
- 2013: 2
- 2014: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2019: 1
- 2021: 1
- 2022: 2
- 2024: 2
- 2026: 1

## Most-cited predicates
- K002523: Advantage Drive System (2000), cited by 12
- K011444: Anspach Emax Drill System (2001), cited by 9
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery) (2001), cited by 4
- K132264: PRIMADO2 Total Surgical System (2013), cited by 3
- K003612: Microspeed EC Motorsystem GD650/GD653 (2001), cited by 3
- K053526: Microspeed Uni Motor System (2006), cited by 3
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) (2001), cited by 3
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools (2017), cited by 3
- K163565: MR8 Drill System (2017), cited by 3
- K173066: OSSEODUO Shaver and Drill System (2018), cited by 3

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