# K143127: CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style

- Pathway: 510(k) (Traditional)
- Applicant: Dispo-Med (Malaysia) Sdn Bhd
- Decided: Feb 13, 2015 after 105 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 K950387 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010024: O2/CO2 Nasal Filterline, Oridion Medical 1987, Ltd. (2001) Summary page 4.
- K011050: Microstream Oral Nasal Cannula Filterline, Oridion Medical 1987, Ltd. (2001) Summary page 4.
- K980325: Microstream Nasal Cannula Filterline, Oridion Medical, Ltd. (1998) Summary page 4.
- K980327: Microstream Filterline Icu, Oridion Medical, Ltd. (1998) Summary page 8.

## Indications for use
The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor. Environment of use – hospital, sub-acute, and pre-hospital settings Patient population – Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.

Source page: https://510kreport.com/device/K143127
Methodology: https://510kreport.com/methodology