# DRN: Device, Counter-Pulsating, External

- Device class: 2; regulation: 21 CFR 870.5225; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 285 days (middle half 285–285)
- Recalls: 1 (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)
- 2005: 1
- 2006: 1
- 2008: 1
- 2009: 1
- 2013: 1
- 2015: 1
- 2018: 1
- 2019: 1
- 2020: 2
- 2025: 1

## Most-cited predicates
- K020857: Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter (2002), cited by 5
- K940264: Vasogenics Eecp-MC2 (1995), cited by 4
- K023016: Nicore Model NCP-1 External Counterpulsation Device (2002), cited by 3
- K042413: Acs Model NCP-2 (2004), cited by 2
- K792354: The Circulator Boot (1980), cited by 2
- K022107: Cardiassist Counterpulsation System, Model Mark 3000 (2002), cited by 2
- K130439: External Counterpulsation Device with SP02 Mornitoring (2013), cited by 2
- K023427: Cardiassist Counterpulsation System, Model Mark 3000 (2003), cited by 1
- K012141: Aecp-a, Automatic External Counterpulsation Device (2001), cited by 1
- K833627: Circulator Miniboot (1984), cited by 1

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