# K050381: CS Medical TTCF Gas Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cs Medical, Inc.
- Decided: Jul 13, 2005 after 148 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- 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 K981078 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981078: Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000, Transtracheal Systems (1998) Summary page 1.

## Indications for use
TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.

Source page: https://510kreport.com/device/K050381
Methodology: https://510kreport.com/methodology