# K100950: Venner Pneux P.Y. (TM) Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Venner Medical (Singapore) Pte, Ltd.
- Decided: Jul 13, 2010 after 98 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- 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
- K192511: Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm,  Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm (2020), 0 descendants of its own

## Indications for use
The Venner PneuxP.v.Tm Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted intb the patient's trachea via a tracheostomy stoma during extended periods (not mare;than 30 days) of intensive ot critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space.

Source page: https://510kreport.com/device/K100950
Methodology: https://510kreport.com/methodology