FDA.report

510(k) K242921

Device
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
510(k) number
K242921
Product code
BTO
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-10
Date received
2024-09-24
Regulation
868.5800
Classification name
Tube, Tracheostomy (W/Wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Joseph Chang
Address
# 12, Ln. 4-30, Chyuan-Zhou Rd., Hou-Li Dist. Taichung City TW 42142 42142

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code BTO

510(k)DeviceApplicantDecision date
K233713Pilling Tracheostomy TubesTeleflex Medical2024-03-22
K192511Venner 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 mmVenner Medical (Singapore) Pte, Ltd.2020-07-22
K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.2018-04-10
K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH2012-05-24
K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULARegulatory and Marketing Services, Inc.2011-03-24
K100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEVenner Medical (Singapore) Pte, Ltd.2010-07-13
K100480ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACHVitaltec Corporation2010-06-11
K100283VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTICCook, Inc.2010-04-23
K083031PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KITSmiths Medical Asd, Inc.2009-08-18
K073702PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTORLazarus Medical, LLC2008-06-26
K062104TALKING TRACHEngineered Medical Systems, Inc.2007-04-20
K060945PORTEX PERCUTANEOUS TRACHEOSTOMY KITSmiths Medical International2006-06-19
K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470Tracoe Medical GmbH2005-10-25
K050379CS MEDICAL ADULT TTCF CATHETERCs Medical, Inc.2005-07-12
K042684WELL LEAD TRACHEOSTOMY TUBEWell Lead Medical Instruments2005-02-17