# K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Feb 9, 1998 after 26 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952621 (1995). 4 ancestors in all.
44 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962334: EML105 Electrolyte Metabolite Analyzer, Radiometer America, Inc. (1996) Summary page 1.
- K973367: ABL555 Blood Gas, Electrolyte & Metabolite System, Radiometer America, Inc. (1997) Summary page 1.

## Most influential descendants
- K992859: ABL700 Series Analyzer with Autocheck Module (2000), 31 descendants of its own
- K041874: ABL800 Flex (2004), 29 descendants of its own
- K050869: Modification to ABL800 Flex (2005), 18 descendants of its own
- K991417: Abl 735 Analyzer (1999), 16 descendants of its own
- K092686: ABL90 Flex Series (2010), 12 descendants of its own

## Recalls of this device
- Jul 5, 2013 · Class II · Z-1075-2014: RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
- Apr 7, 2011 · Not classified · Z-2571-2011: Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of 
- Sep 29, 2005 · Not classified · Z-1386-06: Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too lo
- Sep 19, 2005 · Not classified · Z-1323-06: Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
- Feb 1, 2005 · Not classified · Z-1314-06: The CI membrane units generate too low values for status and sensitivity during calibration.

## Indications for use
ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO,, pO, , cNa*, cK*, cCa**, cCL’, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO, and pCO, on expired air.

Source page: https://510kreport.com/device/K980130
Methodology: https://510kreport.com/methodology