Cleared Special

K253063 - Venti-Trach Tracheostomy Tube (570 Series)

Also marketed or referenced as:
Venti-Trach Tracheostomy Tube (571 Series) Venti-Trach Tracheostomy Tube (580 Series) Venti-Trach Tracheostomy Tube (581 Series)

K253063 is an FDA 510(k) clearance for Venti-Trach Tracheostomy Tube (570 Series), manufactured by Vitaltec Corporation. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Special 510(k) pathway after a 354-day FDA review.

K253063 · Vitaltec Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
354d
Days
Class 2
Risk

K253063 is an FDA 510(k) clearance for the Venti-Trach Tracheostomy Tube (570 Series). Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Vitaltec Corporation (Taichung City, TW). The FDA issued a Cleared decision on September 11, 2026 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vitaltec Corporation devices

FDA 510(k) Submission Details - K253063

510(k) Number K253063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date September 11, 2026
Days to Decision 354 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 140d · This submission: 354d
Pathway characteristics
Modification to existing cleared device.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Ruscert Technology Co., Ltd.
Ming-Yie Jan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 72
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K253063.
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm
K242921 · Vitaltec Corporation · Jun 2025
Pilling Tracheostomy Tubes
K233713 · Teleflex Medical · Mar 2024
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
K192511 · Venner Medical (Singapore) Pte, Ltd. · Jul 2020
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384 · Smiths Medical Ads, Inc. · Apr 2018
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
K120079 · Primed Halberstadt Medizintechnik GmbH · May 2012
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K101721 · Regulatory and Marketing Services, Inc. · Mar 2011