# K122539: Measurement of PH in Pleural Fluid on Blood Gas System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 19, 2013 after 241 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K872888 (1987). 4 ancestors in all.
4 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)
- K110416: ABL835 Flex Analyzer with Pleural PH, Radiometer Medical Aps (2011) Summary page 1.

## Most influential descendants
- 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

## Indications for use
RAPIDPoint® 400/405/500 systems are intended for in vitro testing of pleural fluid samples for the pH parameter. Test systems are intended for use in point of care or laboratory settings. The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. The following critical value applies to pleural fluid pH: pH > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement < 7.3 are referred to as complicated parapneumonic effusions, and are exudative in nature.

Source page: https://510kreport.com/device/K122539
Methodology: https://510kreport.com/methodology