# K052582: Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Oct 14, 2005 after 24 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001814 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023454: Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and Accessories, Datex-Ohmeda (2003) Summary page 1.

## Recalls of this device
- Jun 11, 2014 · Class I · Z-2068-2014: Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical dec

## Indications for use
The Datex-Ohmeda S/5 Single-width airway module, E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. E-miniC is indicated for monitoring patients weighing more than 5kg (11 lbs.). The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K052582
Methodology: https://510kreport.com/methodology