# K012394: Oridion Mac-Line Oral 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864199 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011050: Microstream Oral Nasal Cannula Filterline, Oridion Medical 1987, Ltd. (2001) Summary page 2.
- K864199: Salter Labs #4001 Oral Nasal CO2 Sampling Cannula, Salter Labs (1987) Summary page 2.

## Indications for use
The Oridion MAC-Line Oral Nasal Cannula sample line device 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 Oridion MAC-Line Oral 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 COz 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/K012394
Methodology: https://510kreport.com/methodology