# K982277: Modification to Stat Profile Phox Blood Gas Analyzer (K980991)

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Jul 22, 1998 after 23 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 Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, PCO2, PO2, oxygen saturation (S02%), hematocrit (Hct), and Hemoglobin (Hb) in heparinized whole blood and pCO2 and PO2 in expired (exhaled) gases.

Source page: https://510kreport.com/device/K982277
Methodology: https://510kreport.com/methodology