Ventilator, Continuous, Non-Life-Supporting

FDA product code MNS · 47 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5895
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1996-02-09 – 2026-04-08

MNS 2026-04-08

myAir

Applicant Resmed Corp

K number K251889

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MNS 2026-03-17

BreathePal Bilevel (GFM50-MD2201)

Applicant Compal Electronics, Inc.

K number K252078

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MNS 2026-02-23

Mariana Minerva; Mariana Nimbus

Applicant Resmed Pty , Ltd.

K number K251661

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MNS 2024-12-13

Vivo 1, Vivo 2

Applicant Breas Medical AB

K number K240778

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MNS 2023-07-13

ReddyPort Elbow

Applicant Smd Manufacturing, LLC

K number K231064

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MNS 2022-12-05

BPAP System

Applicant BMC Medical Co., Ltd.

K number K213169

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MNS 2018-01-19

ReddyPort NIV Access Elbow

Applicant Smd Manufacturing, LLC

K number K171827

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MNS 2017-01-19

Juno VPAP ST-A

Applicant Resmed, Ltd.

K number K161492

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MNS 2016-09-09

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

Applicant Resmed, Ltd.

K number K161487

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MNS 2016-04-13

Juno VPAP ST-A

Applicant Resmed, Ltd.

K number K153061

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MNS 2013-11-22

EASYCARE ONLINE

Applicant Resmed, Ltd.

K number K132371

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MNS 2013-03-21

S9 VPAP TX

Applicant Resmed, Ltd.

K number K123511

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MNS 2013-03-14

EASYCARE ONLINE

Applicant Resmed, Ltd.

K number K123557

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MNS 2012-11-13

VPAP S-A

Applicant Resmed, Ltd.

K number K122324

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MNS 2012-05-25

VPAP TX

Applicant Resmed, Ltd.

K number K113714

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MNS 2012-03-29

VPAP ST-A

Applicant Resmed, Ltd.

K number K113288

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MNS 2012-03-27

RESSCAN

Applicant Resmed, Ltd.

K number K113815

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MNS 2012-02-01

BIPAP A 30 VENTILATORY SUPPORT SYSTEM

Applicant Respironics, Inc.

K number K113053

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MNS 2011-12-29

VPAP TX

Applicant Resmed, Ltd.

K number K112914

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MNS 2011-10-04

OXIMETRY INTERFACE KIT

Applicant Philips Respironics, Inc.

K number K111378

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MNS 2011-03-24

BIPAP AVAPS VENTILATORY SUPPORT SYSTEM

Applicant Respironics, Inc.

K number K102465

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MNS 2010-09-02

BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK

Applicant Respironics, Inc.

K number K101130

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MNS 2010-03-22

VPAP III ST-A

Applicant Resmed, Ltd.

K number K093731

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MNS 2010-01-26

DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES

Applicant Sunrise Medical

K number K093070

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MNS 2010-01-22

BIPAP AVAPS VENTILATORY SUPPORT SYSTEM

Applicant Respironics, Inc.

K number K092818

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MNS 2009-12-22

VPAP TX

Applicant Resmed, Ltd.

K number K092186

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MNS 2009-10-30

BIPAP AUTOSV ADVANCED

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K090539

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MNS 2009-08-05

BIPAP SYNCHRONY 2

Applicant Respironics, Inc.

K number K092043

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MNS 2009-03-04

BIPAP AUTOSV

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K090248

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MNS 2007-08-08

BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K071509

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MNS 2007-05-08

BIPAP SYNCHRONY WITH AVAPS

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K070328

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MNS 2007-02-22

BIPAP AUTOSV

Applicant Respironics, Inc.

K number K063540

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MNS 2007-02-20

BIPAP SYNCHRONY

Applicant Respironics, Inc.

K number K063533

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MNS 2006-05-26

BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30

Applicant Breas Medical AB

K number K060546

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MNS 2006-04-07

VPAP III ST-A/KIDSTA MASK SYSTEM

Applicant Resmed, Ltd.

K number K060105

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MNS 2006-01-04

BIPAP FOCUS

Applicant Respironics (Ireland) Limited

K number K053168

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MNS 2005-08-16

VPAP ADAPT

Applicant Resmed, Ltd.

K number K051364

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MNS 2004-06-07

VPAP III ST-A

Applicant Resmed, Ltd.

K number K033276

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MNS 2004-01-14

NASAL-AIR CRITICAL CARE

Applicant Innomed Technologies

K number K031896

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MNS 2003-07-30

BIPAP HARMONY VENTILATORY SUPPORT SYSTEM

Applicant Respironics, Inc.

K number K031656

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MNS 2002-03-20

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX

Applicant Respironics, Inc.

K number K020777

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MNS 2001-12-20

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM

Applicant Respironics, Inc.

K number K012323

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MNS 2000-03-20

BIPAP SYNCHRONY HC

Applicant Respironics, Inc.

K number K992530

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MNS 1999-05-19

BIPAP HARMONY S/T, MODEL 1001445

Applicant Respironics, Inc.

K number K984407

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MNS 1998-06-24

SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM

Applicant Resmed Corp

K number K974417

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MNS 1997-02-20

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV

Applicant Healthdyne Technologies, Inc.

K number K962517

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MNS 1996-02-09

PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM

Applicant Puritan Bennett Corp.

K number K942210

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