# K012395: Mac-Line 02/CO2 Nasal Cannula Sample Line

- Pathway: 510(k) (Special)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Aug 15, 2001 after 19 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915228 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915228: Disposable CO2 Gas Sampling/Oxygen Delivery Cannul, Hospitak, Inc. (1992) Summary page 2.
- (no number) Oridion O₂/CO₂ Microstream Nasal Cannula Filterline: named in the summary without a submission number
- (no number) Salter Laboratories Model 4701 CO₂ Gas sampling/Oxygen delivery Cannula: named in the summary without a submission number

## Recalls of this device
- Feb 16, 2012 · Not classified · Z-1333-2012: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
- Feb 16, 2012 · Not classified · Z-1334-2012: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
- Dec 1, 2011 · Not classified · Z-1348-2012: Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet

## Indications for use
The MAC-Line O,/CO, Nasal Cannula sample line device is used whenever the physician needs to measure the CO, in an adult or pediatric non intubated subject’s breathing via a nasal cannula while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

Source page: https://510kreport.com/device/K012395
Methodology: https://510kreport.com/methodology