# K213518: CARESCAPE CO2 Microstream parameter

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 12, 2022 after 160 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: 15 generations back to K962603 (1997). 70 ancestors in all.
No later device cites it as a predicate yet.
1 of 71 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150272: Capnostream 35 Portable Respiratory Monitor, Oridion Medical 1987, Ltd. (2015) Summary page 4.

## Indications for use
The CARESCAPE™* CQO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines. The CARESCAPE™* CQO2 - Microstream™ parameter is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.

Source page: https://510kreport.com/device/K213518
Methodology: https://510kreport.com/methodology