Cleared Traditional

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

K251216 · Barbaras Development, Inc. · Anesthesiology

Jun 2025

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K251216 is an FDA 510(k) clearance for the 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Barbaras Development, Inc. (Newbury Park, US). The FDA issued a Cleared decision on June 4, 2025, 47 days after receiving the submission on April 18, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K251216 FDA.gov
FDA Decision	Cleared 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