Cleared Traditional

5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 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 · Vitaltec Corporation · Anesthesiology

Jun 2025

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K242921 is an FDA 510(k) clearance for the 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 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, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Vitaltec Corporation (Taichung City, TW). The FDA issued a Cleared decision on June 10, 2025, 259 days after receiving the submission on September 24, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number	K242921 FDA.gov
FDA Decision	Cleared 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