# CBZ: Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

- Device class: 2; regulation: 21 CFR 868.1170; FDA's rule: 510(k) required
- FDA decisions: 10
- 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)
- 1980: 1
- 1981: 1
- 1986: 1
- 1989: 1
- 1991: 2
- 1992: 1
- 1993: 1
- 1997: 1
- 2002: 1

## Most-cited predicates
- K970906: Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor (1997), cited by 4
- K020967: Terumo Khuri Myocardial PH Monitoring System (2002), cited by 1
- K862114: Khuri Regional Tissue PH Monitor (1986), cited by 1

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