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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K242921
Device Name 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
Applicant
Vitaltec Corporation
# 12, Ln. 4-30, Chyuan-Zhou Rd., Hou-Li Dist.
Taichung City,  TW 42142
Applicant Contact Joseph Chang
Correspondent
Ruscert Technology Co., Ltd.
8f., # 187, Lequn 2nd Rd., Zhongshan Dist.
Taipei City,  TW 10462
Correspondent Contact Ming-Yie Jan
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/24/2024
Decision Date 06/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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