# K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: May 25, 2005 after 27 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- 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: 1 generation back to K001814 (2000). 1 ancestor in all.
118 later devices descend from it; 8 cite it directly.
8 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001814: Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories, Datex-Ohmeda (2000) Summary page 2.

## Most influential descendants
- K103604: Isa CO2, Isa AX+, Isa or+ (2011), 91 descendants of its own
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own

## Recalls of this device
- Apr 24, 2015 · Class II · Z-1680-2015: A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Th
- May 23, 2014 · Class II · Z-1808-2014: Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respira

## Indications for use
The Datex-Ohmeda S/5 MT Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patient's respiration (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption V02, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N20+02 mixtures. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K051092
Methodology: https://510kreport.com/methodology