# KHS: Enzymatic, Carbon-Dioxide

- Device class: 2; regulation: 21 CFR 862.1160; FDA's rule: 510(k) required
- FDA decisions: 86
- 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)
- 2007: 2
- 2008: 1
- 2009: 1
- 2010: 3
- 2011: 1
- 2012: 2
- 2013: 2
- 2014: 1
- 2016: 1
- 2017: 1

## Most-cited predicates
- K031879: Cobas Integra Carbon Dioxide Assay (2003), cited by 4
- K844987: Roche Reagents Reagent for CO2 (1985), cited by 2
- K001133: Vitro Chemistry Products ECO2 Slide & Calibrator Kit 2 (2000), cited by 2
- K042362: Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12 (2004), cited by 2
- K032377: Roche Diagnostics Hitachi Bicarbonate Liquid (2003), cited by 2
- K120765: Vitros Chemistry Products ECO2 Slides (2012), cited by 1
- K070251: Carbon Dioxide Liquid Stable Reagent (2007), cited by 1
- K113435: Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent (2012), cited by 1
- K100289: Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781 (2010), cited by 1
- K061238: Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent Cartridge (2006), cited by 1

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