# K181981: CO2 Sampling Line

- Pathway: 510(k) (Traditional)
- Applicant: Tylenol Medical Instruments Co., Ltd.
- Decided: Feb 6, 2019 after 196 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: 2 generations back to K863703 (1986). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151421: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines, Salter Labs (2016) Summary page 4.

## Most influential descendants
- K251216: 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (2025), 0 descendants of its own

## Indications for use
The CO2 Sample Lines are intended to be used where exhaled gas is monitored. The intended population: Patients requiring expired gas monitoring, adult to pediatrics The intended environment of use:Hospital-OR, sub-acute, and pre-hospital settings

Source page: https://510kreport.com/device/K181981
Methodology: https://510kreport.com/methodology