# JFL: Ph Rate Measurement, Carbon-Dioxide

- Device class: 2; regulation: 21 CFR 862.1160; FDA's rule: 510(k) required
- FDA decisions: 28
- 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)
- 1982: 2
- 1984: 1
- 1987: 1
- 1990: 3
- 1993: 5
- 1994: 1
- 1996: 4
- 2001: 1
- 2004: 1
- 2020: 1

## Most-cited predicates
- K191298: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), cited by 1
- K014034: Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro) (2001), cited by 1

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