# K110416: ABL835 Flex Analyzer with Pleural PH

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Mar 24, 2011 after 38 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.
5 later devices descend from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- K122539: Measurement of PH in Pleural Fluid on Blood Gas System (2013), 4 descendants of its own
- K192240: RAPIDPoint 500e Blood Gas System (2020), 3 descendants of its own
- K223857: i-STAT G3+ cartridge with the i-STAT 1 System (2023), 1 descendant of its own
- K244014: i-STAT CG4+ cartridge with the i-STAT 1 System (2025), 0 descendants of its own
- K230285: i-STAT CG8+ cartridge with the i-STAT 1 System (2023), 0 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 

## Indications for use
The ABL835 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 effuisions with a pH of <7.3 are referred as complicated parapneumonic effusions; they are exudative in nature.

Source page: https://510kreport.com/device/K110416
Methodology: https://510kreport.com/methodology