# K213911: Microstream CO2 NanoPod

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jul 29, 2022 after 226 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 Microstream™ CO2 NanoPod, when connected to the host monitor, is intended to provide 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™ and Microstream™ Advance CO2 sampling lines. The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up. IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SPO2 data to the NanoPod in order to calculate these parameters. The Microstream™ CO2 NanoPod is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care. Contraindications: The device is not to be used as an apnea monitor.

Source page: https://510kreport.com/device/K213911
Methodology: https://510kreport.com/methodology