# DRM: Compressor, Cardiac, External

- Device class: 2; regulation: 21 CFR 870.5200; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 232 days (middle half 214–251)
- Recalls: 7 (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)
- 2006: 4
- 2008: 2
- 2009: 1
- 2010: 1
- 2012: 1
- 2014: 1
- 2016: 2
- 2018: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K851139: Thumper Cardiopulmonary Resuscitator 1005 (1985), cited by 5
- K972525: Thumper (1997), cited by 5
- K011046: Autopulse, Model 100 (2001), cited by 4
- K040453: Autopulse Resuscitation System, Model 100 (2004), cited by 4
- K063602: Autopulse Resuscitation System  MODEL100 (2006), cited by 3
- K022345: Autopulse Resuscitation System (2002), cited by 3
- K090422: LUCAS 2 (2009), cited by 3
- K072527: Autopulse Resuscitation System, Model 100 (2008), cited by 2
- K032852: Modification to: Autopulse Resuscitation System Model 100 (2003), cited by 2
- K161768: LUCAS 3 Chest Compression System (2016), cited by 1

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