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BSK — Cuff, Tracheal Tube, Inflatable Class II

FDA Device Classification

Classification Details

Product Code
BSK
Device Class
Class II
Regulation Number
868.5750
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243562idmedCuffGuardAugust 12, 2025
K242642shanghai longmann tech coCuffTrekMarch 7, 2025
K220854aw technologies apsTrachCuff Cuff ControllerApril 14, 2023
K221477hospitech respirationAG100sDecember 29, 2022
K202874covidienPuritan Bennett Cuff Pressure ManagerJanuary 9, 2021
K192611biovo technologiesCuffixAugust 13, 2020
K191858kal-medPylant MonitorFebruary 24, 2020
K182548tianjin medis medical device coAccucuff Cuff Pressure IndicatorJanuary 25, 2019
K180991hospitech respirationAG 100sOctober 12, 2018
K173914vortran medical technology 1VORTRAN Cuff Inflator (VCI)May 25, 2018
K152778tracoe medicalTRACOE Cuff Pressure MonitorDecember 21, 2016
K152865tracoe medicalTRACOE smart Cuff ManagerSeptember 27, 2016
K150157hospitech respirationAnapnoGuard 100 Respiratory Guard SystemFebruary 16, 2016
K150893hamilton medicalIntelliCuffJanuary 29, 2016
K142103teleflexmedicalCUFF PILOT, SURE SEALMay 8, 2015
K122721hospitech respirationAG GUFFILLMay 3, 2013
K112915spiritus technologiesSPIRTIUS CUFF INFLATION SYRINGEMay 25, 2012
K113644instrumentation industriesPILOT TUBE REPAIR KITJanuary 26, 2012
K110631venner medical (singapore) pteVENNER TRACHEAL SEAL MONITORJuly 28, 2011
K102674ventlabCUFF SENTRYJuly 22, 2011