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Microstream CO2 NanoPod

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213911

by Covidien llc

Identifiers

510(k) Number
K213911 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Microstream CO2 NanoPod is a capnography module designed to continuously measure carbon dioxide (CO₂) concentrations in gas mixtures. Classified as an Anesthesiology device under product code CCK, it integrates with existing patient monitoring systems to provide real-time respiratory monitoring during anesthesia procedures.

This device is intended for use in clinical settings where precise CO₂ monitoring is required, such as operating rooms and procedural suites. Supplied as a reusable, mains-powered unit, it adheres to FDA clearance (K213911) under the Traditional 510(k) pathway, with no explicit sterility or single-use designation. Its integration capabilities and durability are noted for compatibility with existing monitoring platforms.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Microstream™ CO₂ NanoPod OEM module - Medtronic, PDF MicrostreamTM CO2 NanoPodTM OEM Information Sheet - Medtronic, K213911 FDA 510 (k) - Microstream CO2 NanoPod | Covidien, LLC, Microstream CO2 NanoPod

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien llc
FDA Applicant
Covidien, LLC

Sources (1)

  • FDA 510(k) K213911 24 fields · synced Sep 19, 2026