# K013729: Stat Profile Phox Basic Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Jan 15, 2002 after 67 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use by healith care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2 and p0O2 in heparinized whole blood. Measurements of blood gases and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Source page: https://510kreport.com/device/K013729
Methodology: https://510kreport.com/methodology