# K100777: ABL837 Flex Analyzer

- Pathway: 510(k) (Abbreviated)
- Applicant: Radiometer Medical Aps
- Decided: Dec 10, 2010 after 267 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
Longest line of descent: 2 generations back to K872888 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050423: Omni Modular, Omni C and Omni S Analyzer (PH Electrode), Roche Diagnostics (2005) Summary page 2.

## 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 

## Indications for use
The ABL837 FLEX analyzer is intended for: in vitro testing of pleural fluid samples for the pH parameter The pH measurement of pleural fluid can be a clinically usefuil tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a PH of <7.3 are referred as complicated parapneumonic effusions; they are exudative in nature.

Source page: https://510kreport.com/device/K100777
Methodology: https://510kreport.com/methodology