# K023454: Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and Accessories

- Pathway: 510(k) (Abbreviated)
- Applicant: Datex-Ohmeda
- Decided: Apr 23, 2003 after 190 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: 1 generation back to K001814 (2000). 1 ancestor in all.
13 later devices descend from it; 2 cite it directly.
3 of 15 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)

## Most influential descendants
- K043276: Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module (2004), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own
- K130584: Monitor B40 (2013), 8 descendants of its own
- K133576: Monitor B40 (2014), 7 descendants of its own
- K151063: Monitor B40 (2015), 5 descendants of its own

## Indications for use
The Datex-Ohmeda Sf 5 Singlewidth airway module, M-miniC and accessories is indicated for monitoring C 0 2 and respiration rate of all hospital patients. M-minic is indicated for monitoring patients weighing more than 5kg (11 lbs.). The device is indcated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K023454
Methodology: https://510kreport.com/methodology