# K012391: Mac-Line 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: 3 generations back to K950387 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863703: Salter Labs Model 4000 Nasal CO2 Sample Line, Salter Labs (1986) Summary page 2.
- K980325: Microstream Nasal Cannula Filterline, Oridion Medical, Ltd. (1998) Summary page 1.

## 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.
- Dec 1, 2011 · Not classified · Z-1346-2012: Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
- Dec 1, 2011 · Not classified · Z-1347-2012: Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet

## Indications for use
The MAC-Line CO, Nasal Cannula sample line is used whenever the physician needs to measure the CO,in a patient's breathing in a non intubated patient. The intended use of the MAC-Line CO, Nasal Cannula sample line is to conduct a sample of the patient's breathing from the patient to the gas measurement device for measuring the percentage of CO; in the patient’s exhalation. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.

Source page: https://510kreport.com/device/K012391
Methodology: https://510kreport.com/methodology