# K173797: Stat Profile Prime Plus Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Jul 17, 2018 after 215 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
Longest line of descent: 2 generations back to K061830 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110648: Nova Stat Profile Phox Ultra Analyzer System, Nova Biomedical Corporation (2011) Summary page 4.

## Most influential descendants
- K193246: Stat Profile Prime Plus Analyzer System (2020), 0 descendants of its own

## Indications for use
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of pH, Partial Pressure of Carbon Dioxide, and Partial Pressure of Oxygen in heparinized arterial and venous whole blood. pH, pCO2, pO2 Measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

Source page: https://510kreport.com/device/K173797
Methodology: https://510kreport.com/methodology