Class Class II

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (K251216)

K251216 2025-06-04 Traditional
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Description

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line by Barbaras Development, Inc., an FDA 510(k) cleared anesthesiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251216
Clearance Date2025-06-04
Clearance TypeTraditional
Product CodeCCK
Regulation Number868.1400

Categories

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Predicate lineage for K251216

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (K251216) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K181981CO2 Sampling LineTylenol Medical Instruments Co., Ltd.2019
K023579GAS SAMPLING LINESPromedic, Inc.2003

Trace the full predicate network for K251216

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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