Venti-Trach Tracheostomy Tube (4 models)— 510(k) K253063
Substantially EquivalentVitaltec Corporation
FDA 510(k) clearance K253063 for Venti-Trach Tracheostomy Tube (4 models), Substantially Equivalent on 2026-09-11. Applicant: Vitaltec Corporation. Device class: 2.
Summary
Four series of Venti-Trach tracheostomy tubes (570, 571, 580, and 581) cleared together under product code BTO, tracheostomy tubes with or without connectors. Several series in one submission usually means size or cuff variants, not four different devices.
Class II, 21 CFR 868.5800, Anesthesiology panel. Vitaltec filed it as a Special 510(k), so these are modifications to tubes it already had cleared.
It took 354 days, from September 22, 2025 to September 11, 2026. That's almost a year on the pathway FDA built for fast, contained design changes. Clocks that long usually include months on hold while FDA waits for answers to an additional-information request. Vitaltec is in Taichung City, Taiwan.
Clearance details
- Device name as filed
- 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
- Product code
- Code BTO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Taichung City, TW
Recent devices under product code BTO
view all- K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm +3 more
- K233713 — Pilling Tracheostomy Tubes
- 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
- K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
- K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
More clearances from Vitaltec Corporation
view allAdverse events under product code BTO
product code BTO- Death
- 14
- Injury
- 328
- Malfunction
- 1,851
- Total
- 2,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.