# LIX: Aid, Cardiopulmonary Resuscitation

- Device class: 2; regulation: 21 CFR 870.5210; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 268 days (middle half 268–268)
- Recalls: 2 (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)
- 1993: 1
- 1996: 1
- 2001: 2
- 2007: 1
- 2009: 1
- 2012: 2
- 2013: 2
- 2015: 1
- 2018: 2
- 2021: 1

## Most-cited predicates
- K071321: Pocketcpr (2007), cited by 5
- K122050: Cprmeter CPR Feedback Device (2012), cited by 2
- K010526: Modification to the Grip (2001), cited by 2
- K173886: CPRmeter 2 CPR Feedback Device (2018), cited by 2
- K954692: CPR Prompt (1996), cited by 1
- K003937: CPR Ezy Mask and Pad (2001), cited by 1
- K112660: Pocketcpr (2012), cited by 1
- K151702: Reusable Full Silicone Cover (2015), cited by 1

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