# CBT: Arterial Blood Sampling Kit

- Device class: 1; regulation: 21 CFR 868.1100
- FDA decisions: 58
- Recalls: 18 (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)
- 1988: 1
- 1989: 1
- 1990: 4
- 1991: 2
- 1992: 1
- 1993: 5
- 1994: 3
- 1995: 4
- 1997: 1
- 2007: 2

## Most-cited predicates
- K071269: Hemodraw Arterial Blood Sampling System (2007), cited by 1
- K905464: Medical Procedure Kits/Arterial Blood Sampling (1991), cited by 1
- K875117: Ciba Corning Balanced Heparin for CA++ (1988), cited by 1
- K950098: Needle Safety Cover (1995), cited by 1

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