Cleared Traditional

K251216 - 0184 CO2 Sampling line (FDA 510(k) Clearance)

Also includes:
0184T CO2 Sampling line 0139 CO2 Sampling line 0182 CO2 Sampling line

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

K251216 · Barbaras Development, Inc. · Anesthesiology device
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Jun 2025
Decision
47d
Days
Class 2
Risk

K251216 is an FDA 510(k) clearance for the 0184 CO2 Sampling line. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Barbaras Development, Inc. (Newbury Park, US). The FDA issued a Cleared decision on June 4, 2025 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Barbaras Development, Inc. devices

Submission Details

510(k) Number K251216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2025
Decision Date June 04, 2025
Days to Decision 47 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
92d faster than avg
Panel avg: 139d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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

ProMedic, LLC
Paul Dryden

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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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