# K042270: Stat K in Vitro Diagnostic Test System

- Pathway: 510(k) (Traditional)
- Applicant: Stat Chem, Inc.
- Decided: Oct 6, 2004 after 44 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K843530 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915345: Stat K System, Portable Diagnostic Services, Inc. (1992) Summary page 1.
- K011465: Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 Pro, Beckman Coulter, Inc. (2001) Summary page 1.
- K843530: Corning 614 NA/K Analyzer, Corning Medical & Scientific (1984) Summary page 1.

## Indications for use
The StatChem Stat K is a device intended to measure potassium in anticoagulated venous whole blood and assayed within twenty minutes of collection. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. It may be used by a central laboratory or at point of care sites.

Source page: https://510kreport.com/device/K042270
Methodology: https://510kreport.com/methodology