# 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

- Pathway: 510(k) (Traditional)
- Applicant: Venner Medical (Singapore) Pte, Ltd.
- Decided: Jul 22, 2020 after 314 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
Longest line of descent: 1 generation back to K100950 (2010). 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)
- K100950: Venner Pneux P.Y. (TM) Tracheostomy Tube, Venner Medical (Singapore) Pte, Ltd. (2010) Summary page 5.

## Indications for use
The Venner PneuX™ TT (Tracheostomy Tube) is intended to be inserted into the patient’s tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.

Source page: https://510kreport.com/device/K192511
Methodology: https://510kreport.com/methodology