Ventilator, Non-Continuous (Respirator)

FDA product code BZD · 437 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5905
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-04 – 2026-09-25

BZD 2003-06-03

7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS

Applicant Hans Rudolph, Inc.

K number K030822

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BZD 2003-05-28

PAPILLON MASK SET

Applicant Map Medizintechnik Fur Arzt Und Patient GmbH

K number K023068

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BZD 2003-04-09

MIRAGE ACTIVA MASK

Applicant Resmed, Ltd.

K number K030798

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BZD 2003-03-21

MODIFICATION TO NASAL-AIRE

Applicant Innomed Technologies

K number K022465

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BZD 2003-02-11

TWLIGHT, MODEL ISP 9600

Applicant Invacare Corp.

K number K022642

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BZD 2003-01-24

PEGASUS NASAL CPAP SYSTEM

Applicant Sensor Medics Corp.

K number K022192

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BZD 2002-11-27

MIRAGE FULL FACE MASK SERIES 2

Applicant Resmed, Ltd.

K number K023306

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BZD 2002-11-27

MIRAGE FULL FACE MASK SERIES 2

Applicant Resmed, Ltd.

K number K023284

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BZD 2002-11-27

MIRAGE FULL FACE MASK SERIES 2

Applicant Resmed, Ltd.

K number K023244

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BZD 2002-11-14

SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650

Applicant Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits

K number K022934

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BZD 2002-11-01

PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US

Applicant Tyco Healthcare Nancy

K number K020886

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BZD 2002-10-29

SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001

Applicant Worldwide Medical Technologies, LLC

K number K020641

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BZD 2002-08-13

7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT

Applicant Hans Rudolph, Inc.

K number K020759

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BZD 2002-07-16

AUTOSET SPIRIT CPAP SYSTEM

Applicant Resmed Corp

K number K013843

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BZD 2002-07-08

S7 ELITE CP AP SYSTEM

Applicant Resmed Corp

K number K013909

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BZD 2002-07-02

IQ NASAL MASK, MODEL 50160 REV. D

Applicant Sleepnet Corporation

K number K021534

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BZD 2002-06-19

REMSTAR PRO WITH C-FLEX CPAP SYSTEM

Applicant Respironics, Inc.

K number K021861

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BZD 2002-05-22

ORION NASAL CPAP SYSTEM

Applicant Bird Products Corp.

K number K020730

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BZD 2002-01-29

REMSTAR AUTO CPAP SYSTEM

Applicant Respironics, Inc.

K number K012554

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BZD 2002-01-22

WEINMANN SOMNOMASK

Applicant Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits

K number K013738

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BZD 2002-01-08

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

Applicant Lifeguard Medical Products, Inc.

K number K013421

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BZD 2001-11-02

MINIME NASAL MASK, MODEL P/N 50220

Applicant Sleepnet Corporation

K number K013306

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BZD 2001-07-24

MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT

Applicant Sensor Medics Corp.

K number K012034

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BZD 2001-07-23

ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530

Applicant Tiara Medical Systems, Inc.

K number K012207

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BZD 2001-07-11

DEVILBISS 9000 SERIES CPAP, MODEL 9001

Applicant Sunrise Medical Hhg, Inc.

K number K011229

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BZD 2001-06-28

BIPAP PRO BI-LEVEL SYSTEM

Applicant Respironics, Inc.

K number K011714

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BZD 2001-06-25

ORACLE ORAL MASK

Applicant Fisher & Paykel Healthcare, Ltd.

K number K003894

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BZD 2001-06-08

INFANT FLOW SYSTEM, MODEL M672P

Applicant Eme (Electro Medical Equipment) , Ltd.

K number K011516

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BZD 2001-05-04

REMREST

Applicant Medical Industries America, Inc.

K number K002763

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BZD 2001-04-18

DORNIR LC-1 CPAP SYSTEM

Applicant Prym Medical , Ltd.

K number K010704

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BZD 2001-03-29

REMSTAR PLUS CPAP SYSTEM

Applicant Respironics, Inc.

K number K010263

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BZD 2000-10-23

AERO-CLICK

Applicant Map Medizintechnik Fur Arzt Und Patient GmbH

K number K993094

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BZD 2000-09-08

SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876

Applicant Respironics, Inc.

K number K002465

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BZD 2000-09-08

RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223

Applicant Respironics, Inc.

K number K000705

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BZD 2000-09-06

BREEZE SLEEPGEAR WITH DREAMSEAL

Applicant Puritan Bennett Corp.

K number K002001

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BZD 2000-08-15

SANSIBAR CPAP SYSTEM

Applicant Prym Medical , Ltd.

K number K000888

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BZD 2000-08-03

BREAS PV 100 CPAP SYSTEM

Applicant Vital Signs, Inc.

K number K001553

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BZD 2000-07-05

MALLINCKRODT, GOODKNIGHT 418S

Applicant Mallinckrodt Developpement France

K number K001845

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BZD 2000-06-22

BIPAP DUET LX BI-LEVEL SYSTEM

Applicant Respironics, Inc.

K number K000994

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BZD 2000-05-26

SWIVEL ELBOW

Applicant Engineered Medical Systems

K number K000215

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BZD 2000-05-12

AIRPILOTMASK, MODEL TMS-900

Applicant Tiara Medical Systems, Inc.

K number K992192

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BZD 2000-03-07

MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2

Applicant Nellcor Puritan Bennett France Dvpt.

K number K993584

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BZD 2000-01-11

HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682

Applicant Bird Products Corp.

K number K990856

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BZD 1999-12-01

CPAP/PRO CPAP INTERFACE

Applicant Stevenson Industries, Inc.

K number K992384

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BZD 1999-11-26

NASAL AIRE

Applicant Breathing Technologies Corp.

K number K990659

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BZD 1999-11-10

RESPIRONICS TOTAL FACE MASK

Applicant Respironics, Inc.

K number K992969

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BZD 1999-10-27

VIRTUOSO LX SMART CPAP SYSTEM

Applicant Respironics, Inc.

K number K993433

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BZD 1999-10-27

ARIA LX CPAP SYSTEM

Applicant Respironics, Inc.

K number K993307

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BZD 1999-10-27

IQ NASAL MASK, MODEL P/N 50160

Applicant Sleepnet Corporation

K number K993269

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BZD 1999-10-18

OPAP

Applicant Opap, Inc.

K number K991926

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BZD 1999-08-13

MONARCH II MINI MASK

Applicant Respironics, Inc.

K number K992336

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BZD 1999-08-13

INFANT FLOW SYSTEM

Applicant Sensor Medics Corp.

K number K991972

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BZD 1999-07-26

SULLIVAN AUTOSET NASAL CPAP SYSTEM

Applicant Resmed, Ltd.

K number K984428

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BZD 1999-05-28

REUSABLE CONTOUR II NASAL MASK

Applicant Respironics, Inc.

K number K991648

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BZD 1999-04-14

NELLCOR PURITAN BENNETT, GOODKNIGHT 418G

Applicant Nellcor Puritan Bennett France Dvpt.

K number K991150

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BZD 1999-02-24

INFANT FLOW NCPAP MASKS

Applicant Sensor Medics Corp.

K number K984254

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BZD 1999-01-27

INVACARE CPAP

Applicant Invacare Corp.

K number K982242

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BZD 1998-11-17

SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

Applicant Nidek Medical Products, Inc.

K number K980551

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BZD 1998-10-16

SULLIVAN MIRAGE FULL FACE MASK

Applicant Resmed, Ltd.

K number K982530

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BZD 1998-10-14

COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER

Applicant W. Keith Thornton, D.D.S.

K number K981744

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BZD 1998-09-01

SULLIVAN AUTOSET

Applicant Resmed, Ltd.

K number K980721

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BZD 1998-08-04

NASAL INTERFACE MODEL 7910

Applicant Healthdyne Technologies, Inc.

K number K974453

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BZD 1998-07-22

GOODKNIGHT 418 CPAP SYSTEM

Applicant Nellcor Puritan Bennett, Inc.

K number K980365

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BZD 1998-07-10

CPAP HUMIDIFIER (HC 200)

Applicant Fisher & Paykel Electronics , Ltd.

K number K973161

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BZD 1998-06-29

MODEL 7410 VOYAGER

Applicant Healthdyne Technologies, Inc.

K number K974879

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BZD 1998-01-30

INFANT FLOW SYSTEM

Applicant Sensor Medics Corp.

K number K974303

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BZD 1998-01-28

EMS NASAL CPAP MASK

Applicant Engineered Medical Systems

K number K972605

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BZD 1997-07-31

TMS COMFORT SERIES NASAL CPAP MASK

Applicant Tiara Medical Systems, Inc.

K number K964092

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BZD 1997-06-20

SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM

Applicant Resmed, Ltd.

K number K970771

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BZD 1997-06-18

MORPHEE PLUS ALPHA

Applicant Nellcor Puritan Bennett, Inc.

K number K964019

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BZD 1997-05-09

SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM

Applicant Resmed, Ltd.

K number K970516

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BZD 1997-04-18

QUARTET CLINICAL SYSTEM

Applicant Respironics, Inc.

K number K963761

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BZD 1997-04-16

MODEL 1700 TRANQUILITY BILEVEL SYSTEM

Applicant Healthdyne Technologies, Inc.

K number K970173

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BZD 1997-03-28

NASALFLAIR

Applicant Airways Ltd., Inc.

K number K951944

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BZD 1997-01-30

BIPAP DUET SYSTEM

Applicant Respironics, Inc.

K number K964363

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BZD 1996-12-05

WHISPER SWIVEL II EXHALATION PORT

Applicant Respironics, Inc.

K number K962203

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BZD 1996-11-14

PRESSURE VALVE

Applicant Respironics, Inc.

K number K963250

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BZD 1996-10-23

DPAP STEALTH SLEEPNET MODEL NUMBER 84000

Applicant Sleepnet Corporation

K number K962713

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BZD 1996-09-30

VIRTUOSO SMART CPAP SYSTEM

Applicant Respironics, Inc.

K number K953930

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BZD 1996-08-15

SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE

Applicant Respironics, Inc.

K number K961915

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BZD 1996-08-01

SULLIVAN VPAP II ST NASAL VPAP SYSTEM

Applicant Resmed, Ltd.

K number K961783

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BZD 1996-07-29

NITELIFE BI-LEVEL CPAP

Applicant Airsep Corp.

K number K943207

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BZD 1996-07-18

SOLO CPAP SYSTEM

Applicant Respironics, Inc.

K number K961626

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BZD 1996-07-02

RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM

Applicant Rescare , Ltd.

K number K952429

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BZD 1996-06-26

MAESTRO CLINICAL REMOTE CONTROL

Applicant Respironics, Inc.

K number K954572

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BZD 1996-06-13

THE IMS DPAP MASK, IMS MODEL NUMBER 82000

Applicant Sleepnet Corporation

K number K953697

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BZD 1996-05-28

SULLIVAN NOSE & MOUTH MASK SYSTEM

Applicant Rescare , Ltd.

K number K952475

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BZD 1996-05-09

THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM

Applicant Puritan Bennett Corp.

K number K960518

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BZD 1996-05-07

CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

Applicant Nidek Medical Products, Inc.

K number K952966

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BZD 1996-02-08

MODEL #7354

Applicant Devilbiss Health Care, Inc.

K number K950849

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BZD 1996-01-31

GEL MASK

Applicant Respironics, Inc.

K number K954207

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BZD 1996-01-31

MODEL 7355

Applicant Devilbiss Health Care, Inc.

K number K952491

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BZD 1996-01-31

RESPIRONICS MONARCH MINI MASK

Applicant Respironics, Inc.

K number K945938

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BZD 1996-01-30

ARIA CPAP SYSTEM

Applicant Respironics, Inc.

K number K953341

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BZD 1995-11-13

PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM

Applicant Puritan Bennett Corp.

K number K952292

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BZD 1995-09-21

PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)

Applicant Healthdyne, Inc.

K number K950331

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BZD 1995-03-29

SPECTRUM(TM) MASK

Applicant Respironics, Inc.

K number K936047

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BZD 1995-02-27

PURITAN-BENNETT COMPANION 320 I/E

Applicant Puritan Bennett Corp.

K number K934804

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BZD 1994-11-28

POSITIVE AIRWAY PRESSURE SYSTEM

Applicant Innovative Medical Systems, Inc.

K number K933184

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BZD 1994-11-10

CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM

Applicant Devilbiss Health Care, Inc.

K number K935979

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