# K251216: 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

- Pathway: 510(k) (Traditional)
- Applicant: Barbaras Development, Inc.
- Decided: Jun 4, 2025 after 47 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K863703 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181981: CO2 Sampling Line, Tylenol Medical Instruments Co., Ltd. (2019) Summary page 5.

## Indications for use
The CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient. Environment of use – hospital, sub-acute, and pre-hospital settings. Patient population – Patients requiring expired gas monitoring.

Source page: https://510kreport.com/device/K251216
Methodology: https://510kreport.com/methodology