Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)

FDA 510(k) K253063 · Vitaltec Corporation

Substantially Equivalent

510(k) numberK253063

Submission

Device name
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)
Applicant
Vitaltec Corporation
Taichung City, TW
Received
September 22, 2025
Decision date
September 11, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTO – Tube, Tracheostomy (W/Wo Connector)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5800
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BTO

510(k)DeviceApplicantDecision
K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…BTO · Traditional Vitaltec Corporation06/10/2025SE
K233713Pilling Tracheostomy TubesBTO · Traditional Teleflex Medical03/22/2024SE
K192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube)…BTO · Traditional Venner Medical (Singapore) Pte, Ltd.07/22/2020SE
K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…BTO · Traditional Smiths Medical Ads, Inc.04/10/2018SE
K120079Primed Tracheostomy Tubes (Multiple)BTO · Traditional Primed Halberstadt Medizintechnik GmbH05/24/2012SE
K101721Well Lead Tracheostomy Tube and Disposable Inner CannulaBTO · Special Regulatory and Marketing Services, Inc.03/24/2011SE
K100950Venner Pneux P.Y. (TM) Tracheostomy TubeBTO · Traditional Venner Medical (Singapore) Pte, Ltd.07/13/2010SE
K100480Rota-Trach Tracheostomy Tube Model Rota-TrachBTO · Traditional Vitaltec Corporation06/11/2010SE
K100283Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes…BTO · Traditional Cook, Inc.04/23/2010SE
K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitBTO · Traditional Smiths Medical Asd, Inc.08/18/2009SE

More from Smiths Medical Asd, Inc.

510(k)DeviceDecision
K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…BTO · Traditional 06/10/2025SE
K100480Rota-Trach Tracheostomy Tube Model Rota-TrachBTO · Traditional 06/11/2010SE

Questions and answers

When was Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) cleared by the FDA?

Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 354 days after the submission was received.

What is the product code of K253063?

The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.