# 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

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Mar 22, 2019 after 275 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: 2 generations back to K864902 (1987). 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)
- K010024: O2/CO2 Nasal Filterline, Oridion Medical 1987, Ltd. (2001) Summary page 4.
- K011536: Microstream O2/CO2 Oral Nasal Filterline, Oridion Medical 1987, Ltd. (2001) Summary page 5.
- K013845: Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line, Oridion Medical 1987, Ltd. (2001) Summary page 5.

## Indications for use
Used to conduct a sample of the subject’s breathing to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The device is to be used with monitors using Microstream™ technology. Used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

Source page: https://510kreport.com/device/K181624
Methodology: https://510kreport.com/methodology