# K012058: Stat Profile Phox Plus L Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Aug 20, 2001 after 49 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K100602: Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips (2011), 1 descendant of its own
- K112955: Nova Statstrip Lactate Hospital Meter System (2012), 0 descendants of its own

## Indications for use
The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, S02%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu and Lac in heparinized whole blood.

Source page: https://510kreport.com/device/K012058
Methodology: https://510kreport.com/methodology