# K091153: Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 13, 2009 after 83 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K020292: Uterine Injector, Catheter Research, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
CO2E reagent, when used in conjunction with UniCel® DxC 800 System and SYNCHRON® Systems AQUA CAL 1 and 3, is intended for the quantitative determination of Carbon Dioxide in human serum or plasma.

Source page: https://510kreport.com/device/K091153
Methodology: https://510kreport.com/methodology