# K992859: ABL700 Series Analyzer with Autocheck Module

- Pathway: 510(k) (Special)
- Applicant: Radiometer America, Inc.
- Decided: Jan 10, 2000 after 138 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861087 (1986). 13 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System, Radiometer America, Inc. (1998) Summary page 1.
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760, Radiometer America, Inc. (1998) Summary page 1.
- K972673: Avl 9181 Electrolyte Analyzer, Avl Scientific Corp. (1997) Summary page 1.

## Most influential descendants
- K041874: ABL800 Flex (2004), 29 descendants of its own
- K050869: Modification to ABL800 Flex (2005), 18 descendants of its own
- 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

## Recalls of this device
- Jul 5, 2012 · Class II · Z-2163-2012: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the 
- Jul 5, 2012 · Class II · Z-2162-2012: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the 
- 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
- Jun 17, 2005 · Not classified · Z-1317-06: Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.

## Indications for use
The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO,, pO,, cNa®, cK*, cCa**, cCL", Glucose, Lactate, and Co-oximetry parameters on human artenal/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.

Source page: https://510kreport.com/device/K992859
Methodology: https://510kreport.com/methodology