Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CoSense ETCO Monitor

K-Number: K253119 · 2026-05-29

ApplicantCapnia, Inc.
Decision Date2026-05-29
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CoSense ETCO Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Capnia, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K253119. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoSense ETCO Monitor?

CoSense ETCO Monitor is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Capnia, Inc.. The 510(k) number is K253119.

When did CoSense ETCO Monitor receive FDA 510(k) clearance?

CoSense ETCO Monitor received FDA 510(k) clearance on 2026-05-29, under 510(k) number K253119.

Who is the listed applicant for CoSense ETCO Monitor?

The FDA 510(k) record lists Capnia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoSense ETCO Monitor?

The FDA product code for CoSense ETCO Monitor is CCJ.

Related Devices (Code: CCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd.K201206Pivot Breath SensorCarrot, Inc.K173238ToxCOBedfont Scientific, Ltd.K171129CO Check Pro, CO ScreenMD Diagnostics LimitedK171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc.

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.

↑