# K982928: NPT7 Series PH/Blood Gas and CO-Oximetry System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Jan 6, 1999 after 139 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 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
- K092686: ABL90 Flex Series (2010), 12 descendants of its own
- K120197: ABL90 Flex (2012), 6 descendants of its own
- K122729: ABL90 Flex (2012), 5 descendants of its own
- K131988: ABL90 Flex Analyzer (2013), 3 descendants of its own
- K160153: ABL90 Flex Plus (2016), 2 descendants of its own

## Recalls of this device
- May 1, 2006 · Not classified · Z-1261-06: Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a que
- Jan 12, 2005 · Not classified · Z-1406-06: QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.

## Indications for use
NPT7 Series is a stand-alone blood gas analyzer that measures pH, pCO, pO, ,and Co-oximetry parameters on human arterial/venous and capillary whole blood. The NPT7 Near Patient Testing System in its various configurations is intended for use in laboratory and point-of-care testing of pH, blood gases and co-oximetry parameters on whole blood samples by minimally trained personnel. The device is designed for stationary use as well as use in moving vehicles and air crafts.

Source page: https://510kreport.com/device/K982928
Methodology: https://510kreport.com/methodology