# KRL: Detector, Bubble, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4205; FDA's rule: 510(k) required
- FDA decisions: 14
- Recalls: 4 (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)
- 1984: 1
- 1986: 1
- 1987: 1
- 1991: 1
- 1993: 2
- 1994: 2
- 1996: 2
- 2007: 1
- 2009: 1
- 2011: 1

## Most-cited predicates
- K961364: Automatic Tubing Clamp System (Atc) (1996), cited by 3
- K911632: Capiox (R) Bubble Trap (1991), cited by 2
- K940651: Sarns Ultrasonic Air Sensor (1994), cited by 2
- K864619: Caps Low Level Detector & Detector/Bubble Monitor (1987), cited by 1

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