# K981078: Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000

- Pathway: 510(k) (Traditional)
- Applicant: Transtracheal Systems
- Decided: Jul 23, 1998 after 121 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050381: CS Medical TTCF Gas Delivery System (2005), 0 descendants of its own

## Indications for use
High flow oxygenation for patients requiring supplemental oxygen for the treatment of hypoxemia

Source page: https://510kreport.com/device/K981078
Methodology: https://510kreport.com/methodology