# ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

- Device class: 2; regulation: 21 CFR 874.4250; FDA's rule: 510(k) required
- FDA decisions: 91
- 510(k) review time 2021–2025: median 170 days (middle half 105–227)
- Recalls: 13 (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: 4
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 3
- 2024: 1
- 2025: 1

## Most-cited predicates
- K041523: XPS 3000 System (2004), cited by 7
- K112593: Styker Consolidated Operating Room Equipment (Core) System (2012), cited by 6
- K034004: Diego RF Powered Dissector and Drill System Console (2004), cited by 6
- K943569: Stryker Total Performance System (1995), cited by 6
- K020594: Diego Powered Dissector and Drill System (2002), cited by 5
- K041413: XPS 3000 System (2004), cited by 5
- K965080: Anspach Micromax System (1997), cited by 4
- K073255: XPS 3000 System (2008), cited by 3
- K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) (2008), cited by 3
- K002224: XPS 3000 System (2000), cited by 3

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