# K133516: CO2 Monitoring Line, CO2 Monitoring Line with Filter

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare
- Decided: Apr 30, 2014 after 166 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: 2 generations back to K946044 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122075: Disposable Gas Sampling Line with and Without in-Line Filter, Intersurgical, Inc. (2012) Summary page 1.

## Indications for use
002 Monitoring lines are intended to connect from a patient interface C02 sampling port to the expired gas monitor.

Source page: https://510kreport.com/device/K133516
Methodology: https://510kreport.com/methodology