# K100941: Infinity Mcable - Mainstream CO2

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Apr 23, 2010 after 18 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: 7 generations back to K902859 (1991). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 2.
- K042601: Capnostat 5, Respironics Novametrix, Inc. (2004) Summary page 2.

## Most influential descendants
- K221118: CO2 Mainstream Sensor (2023), 0 descendants of its own

## Indications for use
The Droger Dr~ger Infinty MCable Mainstream C02 sensor is meant to be used for continuous, real time measurement of C02 concentrations of ventilated patients from neonates to adults. This sensor is only intended for use with devices made by Dr~ger Medical, or with devices which are approved for use with Drager C02 components (Drtiger-compatible devices).

Source page: https://510kreport.com/device/K100941
Methodology: https://510kreport.com/methodology