# K192563: Altera gas Sampling Lines

- Pathway: 510(k) (Traditional)
- Applicant: Meditera Tibbi Malzeme San VE Tic AS
- Decided: Jan 17, 2020 after 122 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 K946044 (1994). 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)
- K171678: Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable, Vyaire Medical, Inc. (2018) Summary page 4.

## Indications for use
The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.

Source page: https://510kreport.com/device/K192563
Methodology: https://510kreport.com/methodology