# K962944: Transtracheal Demand Oxygen Controller (Doc-2000)

- Pathway: 510(k) (Traditional)
- Applicant: Transtracheal Systems
- Decided: Oct 23, 1996 after 89 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
1) Conserve the flow of oxygen 2) Deliver oxygen during the inspiration cycle 3) Maintain adequate oxygen saturation of a patient 4) Adjustable time for delay to inspiration alarm 5) Adjustable inspiration time

Source page: https://510kreport.com/device/K962944
Methodology: https://510kreport.com/methodology