# K121927: Microstream Filterline Icu

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Nov 29, 2012 after 150 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: 3 generations back to K950387 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980327: Microstream Filterline Icu, Oridion Medical, Ltd. (1998) Summary page 1.

## Indications for use
The Carinal VitalineTh Set sampling line is intended to provide for C02. measurement of intubated neonates and infants with a Microstreamn monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube. The set is intended for single patient use only.

Source page: https://510kreport.com/device/K121927
Methodology: https://510kreport.com/methodology