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FDA 510(k)

Capnostream™35 Portable Respiratory Monitor (PM35MN)

K-Number: K253030 · 2026-05-01

ApplicantCovidien, LLC
Decision Date2026-05-01
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Capnostream™35 Portable Respiratory Monitor (PM35MN) is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2026-05-01 under approval number K253030. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capnostream™35 Portable Respiratory Monitor (PM35MN)?

Capnostream™35 Portable Respiratory Monitor (PM35MN) is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by Covidien, LLC. The 510(k) number is K253030.

When was Capnostream™35 Portable Respiratory Monitor (PM35MN) approved by the FDA?

Capnostream™35 Portable Respiratory Monitor (PM35MN) received FDA 510(k) clearance on 2026-05-01, under approval number K253030.

What company makes Capnostream™35 Portable Respiratory Monitor (PM35MN)?

Capnostream™35 Portable Respiratory Monitor (PM35MN) is manufactured by Covidien, LLC.

What is the FDA product code for Capnostream™35 Portable Respiratory Monitor (PM35MN)?

The FDA product code for Capnostream™35 Portable Respiratory Monitor (PM35MN) is CCK.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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