# K050423: Omni Modular, Omni C and Omni S Analyzer (PH Electrode)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 22, 2005 after 63 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: 1 generation back to K872888 (1987). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895317: Avl Model 995HB PH/Blood Gas Analyzer, Avl Scientific Corp. (1990) Summary page 1.
- K872888: Ciba Corning 288 PH/Blood Gas System, Ciba Corning Diagnostics Corp. (1987) Summary page 1.

## Most influential descendants
- K110416: ABL835 Flex Analyzer with Pleural PH (2011), 5 descendants of its own
- 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

## Indications for use
The Omni (Modular, C and S) can be used for the measurement of ph in pleural fluid, as long as care is taken to ensure that the specimen to be analyzed is clear of fibrin clots or other debris which may block the sample transport system. The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.

Source page: https://510kreport.com/device/K050423
Methodology: https://510kreport.com/methodology