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BTM — Ventilator, Emergency, Manual (Resuscitator) Class II

FDA Device Classification

Classification Details

Product Code
BTM
Device Class
Class II
Regulation Number
868.5915
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251631laerdal medicalThe BAG manual resuscitator and accessoriesNovember 24, 2025
K243861compact medicalbutterflyBVMApril 25, 2025
K221841archeonEOlife®March 18, 2023
K212905safe bvm corporationSotair DeviceAugust 18, 2022
K210288xiamen compower medical tech. coDisposable Manual ResuscitatorAugust 26, 2021
K181583flexicare medical limitedAdult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use ResuDecember 7, 2018
K170663foremount enterprise coForemount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, ForemounMay 11, 2018
K152931ambuAmbu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR August 29, 2016
K132172laerdal medicalNEONATALIE RESUSCITATORJanuary 15, 2015
K112852a plus medicalBABI PLUS NEONATAL RESUSCITATION BAGJanuary 13, 2012
K102824ambuAMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRICJanuary 28, 2011
K102649neoforce groupNEOPOP INFANT RESUSCITATOR WITH FLOW METERJanuary 6, 2011
K094003hersill, s.lREVIVATORSeptember 17, 2010
K093081microbvm systemsPOCKET BVMFebruary 5, 2010
K082092galemedDISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXEOctober 15, 2008
K073410artivent corporationSAVE RESUSCITATORSeptember 12, 2008
K073171allied healthcare productsRESUSCITATION TIMER, MODEL L770-CPRJanuary 31, 2008
K072021neoforce groupNEOPIP INFANT RESUSCITATORSeptember 12, 2007
K070247ohmeda medicalGIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMApril 20, 2007
K062080allied healthcare productsRESUSCITATION TIMER, MODEL L770-CPROctober 18, 2006