# K221118: CO2 Mainstream Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Draegerwerk AG & CO Kgaa
- Decided: Apr 5, 2023 after 352 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: 8 generations back to K902859 (1991). 33 ancestors in all.
No later device cites it as a predicate yet.
3 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100941: Infinity Mcable - Mainstream CO2, Draeger Medical AG & Co. KG (2010) Summary page 4.

## Indications for use
The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.

Source page: https://510kreport.com/device/K221118
Methodology: https://510kreport.com/methodology