# K013845: Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line

- Pathway: 510(k) (Special)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Nov 29, 2001 after 9 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864902 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011536: Microstream O2/CO2 Oral Nasal Filterline, Oridion Medical 1987, Ltd. (2001)
- K864902: Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu., Salter Labs (1987) Summary page 2.

## Most influential descendants
- K181624: Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line (2019), 0 descendants of its own

## 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.

## Indications for use
The MAC-Line 0,/CO, Oral Nasal Cannula sample line is used whenever the physician needs to collect a sample of the patient's breathing to measure CO, with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation. It can be used for adult, intermediate or pediatric non-intubated patients.

Source page: https://510kreport.com/device/K013845
Methodology: https://510kreport.com/methodology