Cleared Traditional

K242921 - 5300600-5301000 Rota-Trach Disposable S...

Also marketed or referenced as:
5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

K242921 is an FDA 510(k) clearance for 5300600-5301000 Rota-Trach Disposable S..., manufactured by Vitaltec Corporation. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K242921 · Vitaltec Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
259d
Days
Class 2
Risk

K242921 is an FDA 510(k) clearance for the 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, siz.... 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 June 10, 2025 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitaltec Corporation devices

FDA 510(k) Submission Details - K242921

510(k) Number K242921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2024
Decision Date June 10, 2025
Days to Decision 259 days
Submission Type Traditional
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
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 47
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K242921.
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
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031 · Smiths Medical Asd, Inc. · Aug 2009
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · Rusch Intl. · Jul 2002