# CHL: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

- Device class: 2; regulation: 21 CFR 862.1120; FDA's rule: 510(k) required
- FDA decisions: 188
- 510(k) review time 2021–2025: median 266 days (middle half 246–456)
- Recalls: 105 (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)
- 2015: 4
- 2016: 3
- 2017: 1
- 2018: 1
- 2020: 4
- 2021: 2
- 2023: 5
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K110648: Nova Stat Profile Phox Ultra Analyzer System (2011), cited by 9
- K133407: Gem Premier 4000 (2014), cited by 7
- K895317: Avl Model 995HB PH/Blood Gas Analyzer (1990), cited by 6
- K041874: ABL800 Flex (2004), cited by 6
- K946206: Ciba Corning 8-- Series CO-Oximeter (1995), cited by 6
- K940918: I-Stat 200 Portable Clinical Analyzer (1994), cited by 5
- K990092: Avl Omni Modular Analyzer (1999), cited by 4
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System (1998), cited by 4
- K934907: 860 Measurment System (1994), cited by 4
- K002290: Abl-700 Series, Model Abl 7XX (Various Models) (2000), cited by 3

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