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— 510(k) K192511

Clearance details

Applicant

Venner Medical (Singapore) Pte, Ltd.

Product code

Code BTO

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2019-09-12

Decision date

2020-07-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Singapore, SG

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• K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube2018-04-10
• K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE)2012-05-24

• K192120 — Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm2020-02-14
• K191602 — APA Oxy Blade2019-08-02
• K110631 — VENNER TRACHEAL SEAL MONITOR2011-07-28
• K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE2010-07-13
• K093135 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE2010-04-02

Death

14

Injury

328

Malfunction

1,851

Total

2,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →