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 2012-11-05

MINIME 2 NASAL MASK

Applicant Sleepnet Corporation

K number K121692

View details →

BZD 2012-11-01

TAP PAP NASAL PILLOW MASK

Applicant Airway Management, Inc.

K number K122350

View details →

BZD 2012-10-23

GEO

Applicant Resmed, Ltd.

K number K121705

View details →

BZD 2012-10-09

REMSTAR SE

Applicant Respironics, Inc.

K number K122769

View details →

BZD 2012-10-05

SIMPLE T NASAL MASK

Applicant Respironics, Inc.

K number K121631

View details →

BZD 2012-10-02

ESON NASAL MASK

Applicant Fisher & Paykel Healthcare Limited

K number K121597

View details →

BZD 2012-07-27

MOJO, VERASEAL

Applicant Sleepnet Corporation

K number K120463

View details →

BZD 2012-07-17

PERFORMAX PEDIATRIC EE TOTAL FACE MASK

Applicant Respironics, Inc.

K number K120562

View details →

BZD 2012-07-16

HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA

Applicant Hsiner Company

K number K120920

View details →

BZD 2012-07-02

K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

Applicant Curative Medical, Inc.

K number K120285

View details →

BZD 2012-05-25

VPAP ADAPT

Applicant Resmed Corp

K number K113801

View details →

BZD 2012-05-16

APEX MEDICAL ICH CPAP SERIES (9S-007XXX)

Applicant Apex Medical Corp.

K number K120035

View details →

BZD 2012-04-27

RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER

Applicant 3B Products, Inc.

K number K110629

View details →

BZD 2012-04-24

SLEEPWEAVER ELAN NASAL CPAP MASK

Applicant Circadiance, LLC

K number K120757

View details →

BZD 2012-04-20

EASYCARE TX SYSTEM (CONNEXUNS)

Applicant Resmed, Ltd.

K number K113780

View details →

BZD 2012-03-30

SIMPLE T NASAL MASK

Applicant Respironics, Inc.

K number K120145

View details →

BZD 2012-02-23

PILAIRO NASAL PILLOWS MASK

Applicant Fisher & Paykel Healthcare Limited

K number K120027

View details →

BZD 2012-02-16

3B WILLOW

Applicant 3B Products, LLC

K number K112271

View details →

BZD 2012-01-06

MIRAGE QUATTRO

Applicant Resmed, Ltd.

K number K113127

View details →

BZD 2011-12-16

REMSTAR AUTO A-FLEX HT

Applicant Respironics, Inc.

K number K113068

View details →

BZD 2011-12-07

SWIFT FX BELLA

Applicant Resmed, Ltd.

K number K112489

View details →

BZD 2011-11-22

DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL

Applicant Devilbiss Healthcare, LLC

K number K112220

View details →

BZD 2011-11-16

TASMAN

Applicant Resmed, Ltd.

K number K112393

View details →

BZD 2011-11-16

SOYALA SILKGEL FULL FACE MASK

Applicant Weinmann Gerate Fur Medizin GmbH + Co. KG

K number K112167

View details →

BZD 2011-10-13

3B FLEX-LITE

Applicant 3B Products, LLC

K number K103434

View details →

BZD 2011-10-07

BABI PLUS INFANT NASAL CANNULA SYSTEM

Applicant A Plus Medical

K number K110471

View details →

BZD 2011-08-19

INFOSEND GSM

Applicant Fisher & Paykel Healthcare, Ltd.

K number K110316

View details →

BZD 2011-08-01

BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20

Applicant A Plus Medical

K number K110383

View details →

BZD 2011-07-12

EASYFIT SILKGEL NASAL MASK

Applicant Weinmann Gerate Fur Medizin GmbH + Co. KG

K number K110884

View details →

BZD 2011-06-30

S8 ASPEN WITH H4I PLUS

Applicant Resmed Corp

K number K111148

View details →

BZD 2011-06-10

VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03

Applicant Vega Technologies, Inc.

K number K102625

View details →

BZD 2011-06-06

TRUBLUE NASAL MASK

Applicant Respironics, Inc.

K number K110405

View details →

BZD 2011-05-17

IQ VENTILATION NASAL MASK

Applicant Sleepnet Corporation

K number K102317

View details →

BZD 2011-05-06

APEX MEDICAL WIZARD SERIES CPAP MASK

Applicant Apex Medical Corp.

K number K103174

View details →

BZD 2011-03-30

NEOPAP SYSTEM

Applicant Childrens Medical Ventures, LLC

K number K103410

View details →

BZD 2011-03-24

ZEST PETITE NASAL MASK

Applicant Fisher & Paykel Healthcare, Ltd.

K number K103786

View details →

BZD 2011-03-24

PERFORMAX TOTAL FACE MASK

Applicant Respironics, Inc.

K number K103395

View details →

BZD 2011-03-18

S9 VPAP ADAPT WITH H5I

Applicant Resmed, Ltd.

K number K102586

View details →

BZD 2011-03-16

MIRAGE MICRO

Applicant Resmed, Ltd.

K number K110444

View details →

BZD 2011-03-11

NP15

Applicant Weinmann Gerate Fur Medizin GmbH + Co. KG

K number K102515

View details →

BZD 2011-02-17

GOLIFE NASAL MASK

Applicant Respironics, Inc.

K number K110008

View details →

BZD 2011-01-05

S9 VPAP ST WITH H5I

Applicant Resmed, Ltd.

K number K102513

View details →

BZD 2010-12-28

MIRAGE FX

Applicant Resmed, Ltd.

K number K102746

View details →

BZD 2010-12-22

GOLIFE NASAL MASK

Applicant Respironics, Inc.

K number K102502

View details →

BZD 2010-12-10

PIXI PEDIATRIC MASK

Applicant Resmed, Ltd.

K number K102224

View details →

BZD 2010-10-08

FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM

Applicant Fisher & Paykel Healthcare, Ltd.

K number K100011

View details →

BZD 2010-07-13

MODEL 300157 CPAP SYSTEM

Applicant Aeiomed, Inc.

K number K100121

View details →

BZD 2010-06-09

MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)

Applicant Resmed, Ltd.

K number K100772

View details →

BZD 2010-05-13

BABI PLUS INFANT NASAL CANNULA SYSTEM

Applicant A Plus Medical

K number K093716

View details →

BZD 2010-04-27

F&P ICON SERIES CPAP

Applicant Fisher & Paykel Healthcare, Ltd.

K number K094040

View details →

BZD 2010-04-23

PAP-CAP

Applicant Pur-Sleep, Inc.

K number K100343

View details →

BZD 2010-03-10

PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03

Applicant Cardinal Health 207, Inc.

K number K093124

View details →

BZD 2010-02-26

EASYCARE ONLINE

Applicant Resmed, Ltd.

K number K093684

View details →

BZD 2010-02-12

COMFORTGEL NASAL MASK

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K092835

View details →

BZD 2009-11-05

NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD

Applicant Innomed Technologies, Inc./Respcare, Inc.

K number K090804

View details →

BZD 2009-11-02

SLEEPWEAVER NASAL CPAP MASK

Applicant Circadiance, LLC

K number K092362

View details →

BZD 2009-10-02

EASYCARE TX, TX LINK

Applicant Resmed, Ltd.

K number K092026

View details →

BZD 2009-09-28

S8 ASPEN WITH H4I PLUS

Applicant Resmed, Ltd.

K number K091947

View details →

BZD 2009-09-28

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST

Applicant Sunrise Medical

K number K091919

View details →

BZD 2009-09-10

COMFORT TWIN NASAL MASK

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K091843

View details →

BZD 2009-09-03

COMFORT TWIN NASAL MASK

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K091066

View details →

BZD 2009-08-03

REMSTAR AUTO A-FLEX

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K091319

View details →

BZD 2009-08-03

QUATTRO LT

Applicant Resmed, Ltd.

K number K091129

View details →

BZD 2009-07-01

MINIME PEDIATRIC MASK

Applicant Sleepnet Corporation

K number K090935

View details →

BZD 2009-05-29

RESPIRONICS PERFORMAX TOTAL FACE MASK

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K091271

View details →

BZD 2009-05-15

RESPIRONICS SLEEPEASY CPAP SYSTEM

Applicant Respironics, Inc.

K number K091112

View details →

BZD 2009-05-08

REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K090243

View details →

BZD 2009-05-06

MIRAGE ECHO

Applicant Resmed Corp

K number K090490

View details →

BZD 2009-04-22

APEX MEDICAL XT AUTO CPAP 9S-005200

Applicant Apex Medical Corp.

K number K083656

View details →

BZD 2009-04-13

SWIFT FX

Applicant Resmed, Ltd.

K number K090244

View details →

BZD 2009-03-25

COMFORTLITE NASAL MASK

Applicant Respironics, Inc.

K number K082558

View details →

BZD 2009-03-20

RES TRAXX ONLINE, MODEL: R14

Applicant Resmed, Ltd.

K number K083816

View details →

BZD 2009-03-16

ZEST NASAL MASK

Applicant Fisher & Paykel Healthcare, Ltd.

K number K083832

View details →

BZD 2009-01-30

REVOLUTIONFULL FACE MASK

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K082866

View details →

BZD 2009-01-13

VPAP AUTO WITH HUMIDAIRE 3I

Applicant Resmed, Ltd.

K number K082605

View details →

BZD 2009-01-02

RESSCAN-PRO

Applicant Resmed, Ltd.

K number K082983

View details →

BZD 2009-01-02

S8 ADVANCE

Applicant Resmed, Ltd.

K number K082979

View details →

BZD 2008-10-28

DEVILBISS DV5M SMARTLINK SYSTEM

Applicant Sunrise Medical

K number K082209

View details →

BZD 2008-10-09

PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST

Applicant Mallinckrodt Developpement France

K number K082237

View details →

BZD 2008-10-09

MODIFICATION TO MIRAGE MICRO

Applicant Resmed, Ltd.

K number K081321

View details →

BZD 2008-09-12

SLEEPSTYLE 200 AUTO SERIES HC254

Applicant Fisher & Paykel Healthcare, Ltd.

K number K081029

View details →

BZD 2008-09-12

FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK

Applicant Fisher & Paykel Healthcare, Ltd.

K number K080209

View details →

BZD 2008-06-23

LAMIN AIR

Applicant Remgenic, LLC

K number K080516

View details →

BZD 2008-05-16

SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE

Applicant Mallinckrodt Developpement France

K number K080439

View details →

BZD 2008-05-14

CPAP MASK

Applicant Arcimed Laboratories, LLC

K number K071915

View details →

BZD 2008-05-09

SOYALA GEL VENTED

Applicant Weinmann Gerate Fur Medizin GmbH + Co. KG

K number K081014

View details →

BZD 2008-04-25

COMFORTGEL FULL FACE MASK

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K073600

View details →

BZD 2008-04-08

S8 ESCAPE II

Applicant Resmed, Ltd.

K number K080079

View details →

BZD 2008-04-01

VPAP ST

Applicant Resmed, Ltd.

K number K080131

View details →

BZD 2008-03-28

SOYALA FULL FACE MASK GEL VENTED

Applicant Weinmann Gerate Fur Medizin GmbH + Co. KG

K number K073673

View details →

BZD 2008-03-20

SWIFT LT

Applicant Resmed, Ltd.

K number K073638

View details →

BZD 2008-02-08

REUSABLE HEADREST WITH NASAL SEAL

Applicant Aeiomed, Inc.

K number K072993

View details →

BZD 2008-02-01

HRI 6500, 6600 AND 6700 SERIES V2MASKS

Applicant Hans Rudolph, Inc.

K number K071149

View details →

BZD 2008-01-04

TXCONTROL

Applicant Resmed, Ltd.

K number K072615

View details →

BZD 2007-12-27

REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM

Applicant Respironics, Inc.

K number K072996

View details →

BZD 2007-12-19

PERFORMAX TOTAL FACE MASK

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K072592

View details →

BZD 2007-12-14

WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340

Applicant Weinmann Gerate Fur Medizin GmbH + Co. KG

K number K072009

View details →

BZD 2007-12-13

MIRAGE MICRO

Applicant Resmed, Ltd.

K number K072940

View details →

BZD 2007-11-16

GALEMED CPAP MASK

Applicant Galemed Corp.

K number K072755

View details →

BZD 2007-10-10

MIRAGE MICRO

Applicant Resmed, Ltd.

K number K071808

View details →