# K052167: Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Sep 8, 2005 after 30 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962638 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993656: Datex-Ohmeda Tonometry Module M-Tono, Datex-Ohmeda, Inc. (2000) Summary page 1.

## Indications for use
The Datex-Ohmeda Tonometry Module is indicated for monitoring gastrointestinal C02 (PgCO2) and calculation of various gastrointestinal tonometry parameters (gastrointestinal - arterial PCO2 difference, gastrointestinal - end-tidal PCO2 difference and intramucosal pH) when used with a Datex-Ohmeda modular monitoring system. It is indicated for use in hospital patients. The Tonometry module is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K052167
Methodology: https://510kreport.com/methodology