# HBB: Motor, Drill, Pneumatic

- Device class: 2; regulation: 21 CFR 882.4370; FDA's rule: 510(k) required
- FDA decisions: 27
- Recalls: 12 (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)
- 2004: 2
- 2005: 1
- 2006: 1
- 2007: 1
- 2009: 1
- 2010: 2
- 2015: 1
- 2017: 1
- 2018: 1
- 2026: 1

## Most-cited predicates
- K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System (2002), cited by 11
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700 (2009), cited by 5
- K980686: Aesculap Hilan Motor System (1998), cited by 4
- K041754: Stryker Maestro System (2004), cited by 2
- K013091: ZMM 2000 Zeppelin Millennium Motordrill System (2002), cited by 2
- K991625: Komet XK-95 Perforator Motor (MI-102) (1999), cited by 2
- K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (2017), cited by 2
- K953434: Midas Rex Motors, (Midas I, Midas II & Convertible Models) (1996), cited by 2
- K101168: Legend Power Adapter Model: 6475000 (2010), cited by 1
- K960630: Anspahc Speed Reducer (1996), cited by 1

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