ClearanceBrief
Panels › Anesthesiology › Product code MNS · Class 2

Ventilator, Continuous, Non-Life-Supporting

Regulation 868.5895

3510(k)s in 12 months (47 all time)
1recalls in 12 months (21 all time)
13recalls that name a 510(k)
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Top companies in MNS

Company510(k)sRecalls
Resmed Corp190
Philips Respironics, Inc.117
Respironics, Inc.122
Respironics Inc., Sleep & Home Respiratory Group40
BMC Medical Co., Ltd.11
Breas Medical AB20
Smd Manufacturing, LLC20
Compal Electronics, Inc.10
Healthdyne Technologies, Inc.10
Innomed Technologies10
Decided510(k)Device and applicantCode
Apr 8, 2026K251889myAir
Resmed Corp
MNS
Mar 17, 2026K252078BreathePal Bilevel (GFM50-MD2201)
Compal Electronics, Inc., TW
MNS
Feb 23, 2026K251661Mariana Minerva; Mariana Nimbus
Resmed Pty , Ltd., AU
MNS
Dec 13, 2024K240778Vivo 1, Vivo 2
Breas Medical AB, SE
MNS
Jul 13, 2023K231064ReddyPort Elbow
Smd Manufacturing, LLC
MNS
Dec 5, 2022K213169BPAP System
BMC Medical Co., Ltd., CN
MNS
Jan 19, 2018K171827ReddyPort NIV Access Elbow
Smd Manufacturing, LLC
MNS
Jan 19, 2017K161492Juno VPAP ST-A
Resmed, Ltd., AU
MNS
Sep 9, 2016K161487VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
Resmed, Ltd., AU
MNS
Apr 13, 2016K153061Juno VPAP ST-A
Resmed, Ltd., AU
MNS
Nov 22, 2013K132371EASYCARE ONLINE
Resmed, Ltd.
MNS
Mar 21, 2013K123511S9 VPAP TX
Resmed, Ltd.
MNS
Mar 14, 2013K123557EASYCARE ONLINE
Resmed, Ltd.
MNS
Nov 13, 2012K122324VPAP S-A
Resmed, Ltd.
MNS
May 25, 2012K113714VPAP TX
Resmed, Ltd.
MNS
Mar 29, 2012K113288VPAP ST-A
Resmed, Ltd.
MNS
Mar 27, 2012K113815RESSCAN
Resmed, Ltd.
MNS
Feb 1, 2012K113053BIPAP A 30 VENTILATORY SUPPORT SYSTEM
Respironics, Inc.
MNS
Dec 29, 2011K112914VPAP TX
Resmed, Ltd.
MNS
Oct 4, 2011K111378OXIMETRY INTERFACE KIT
Philips Respironics, Inc.
MNS
Mar 24, 2011K102465BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
Respironics, Inc.
MNS
Sep 2, 2010K101130BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
Respironics, Inc.
MNS
Mar 22, 2010K093731VPAP III ST-A
Resmed, Ltd.
MNS
Jan 26, 2010K093070DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
Sunrise Medical
MNS
Jan 22, 2010K092818BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
Respironics, Inc.
MNS
Dec 22, 2009K092186VPAP TX
Resmed, Ltd.
MNS
Oct 30, 2009K090539BIPAP AUTOSV ADVANCED
Respironics Inc., Sleep & Home Respiratory Group
MNS
Aug 5, 2009K092043BIPAP SYNCHRONY 2
Respironics, Inc.
MNS
Mar 4, 2009K090248BIPAP AUTOSV
Respironics Inc., Sleep & Home Respiratory Group
MNS
Aug 8, 2007K071509BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
Respironics Inc., Sleep & Home Respiratory Group
MNS
May 8, 2007K070328BIPAP SYNCHRONY WITH AVAPS
Respironics Inc., Sleep & Home Respiratory Group
MNS
Feb 22, 2007K063540BIPAP AUTOSV
Respironics, Inc.
MNS
Feb 20, 2007K063533BIPAP SYNCHRONY
Respironics, Inc.
MNS
May 26, 2006K060546BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
Breas Medical AB, SE
MNS
Apr 7, 2006K060105VPAP III ST-A/KIDSTA MASK SYSTEM
Resmed, Ltd.
MNS
Jan 4, 2006K053168BIPAP FOCUS
Respironics (Ireland) Limited, IE
MNS
Aug 16, 2005K051364VPAP ADAPT
Resmed, Ltd.
MNS
Jun 7, 2004K033276VPAP III ST-A
Resmed, Ltd.
MNS
Jan 14, 2004K031896NASAL-AIR CRITICAL CARE
Innomed Technologies
MNS
Jul 30, 2003K031656BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
Respironics, Inc.
MNS
Mar 20, 2002K020777BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
Respironics, Inc.
MNS
Dec 20, 2001K012323BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
Respironics, Inc.
MNS
Mar 20, 2000K992530BIPAP SYNCHRONY HC
Respironics, Inc.
MNS
May 19, 1999K984407BIPAP HARMONY S/T, MODEL 1001445
Respironics, Inc.
MNS
Jun 24, 1998K974417SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
Resmed Corp
MNS
Feb 20, 1997K962517MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
Healthdyne Technologies, Inc.
MNS
Feb 9, 1996K942210PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM
Puritan Bennett Corp.
MNS

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