Cleared Traditional

CoSense ETCO Monitor (K253119) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253119 · Capnia, Inc. · Anesthesiology device
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May 2026
Decision
247d
Days
Class 2
Risk

K253119 is an FDA 510(k) clearance for the CoSense ETCO Monitor. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Capnia, Inc. (Foster City, US). The FDA issued a Cleared decision on May 29, 2026 after a review of 247 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Capnia, Inc. devices

Submission Details

510(k) Number K253119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2025
Decision Date May 29, 2026
Days to Decision 247 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 139d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Medical Device Academy, Inc.
Rob Packard

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 27
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K253119.
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