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 2026-09-25

Altis Full Face Mask

Applicant Respironics, Inc.

K number K261262

View details →

BZD 2026-07-23

RXiBreeze PAP System (RXiBreeze 20C)

Applicant Resvent Medical Technology Co., Ltd.

K number K253044

View details →

BZD 2026-06-04

Orion

Applicant Resmed Corp

K number K253553

View details →

BZD 2026-05-27

ResScan Essentials

Applicant Resmed Corp

K number K254104

View details →

BZD 2026-05-21

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

Applicant Dcstar, Inc.

K number K251920

View details →

BZD 2026-04-29

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

Applicant BMC Medical Co., Ltd.

K number K253166

View details →

BZD 2026-04-17

MySleepDash

Applicant Somnetics International, Inc. (Dba Transcend Inc)

K number K252338

View details →

BZD 2026-01-15

Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

Applicant Sleepnet Corporation

K number K251847

View details →

BZD 2026-01-07

DeltaWave Nasal Pillow System

Applicant RemSleep Holdings, Inc.

K number K253939

View details →

BZD 2025-12-15

SleepRes PAP System

Applicant Sleepres, Inc.

K number K251770

View details →

BZD 2025-12-05

Personalized Therapy Comfort Settings (PTCS)

Applicant Resmed Corp

K number K251657

View details →

BZD 2025-06-18

F&P Nova Nasal Mask

Applicant Fisher & Paykel Healthcare Limited

K number K243583

View details →

BZD 2025-05-28

myAir

Applicant Resmed Corp

K number K250624

View details →

BZD 2025-05-23

WiZARD 520 Full Face Mask

Applicant Wellell, Inc.

K number K243023

View details →

BZD 2025-05-19

AirFit F20 Mask System; AirFit F20 NM Mask System

Applicant Resmed Pty , Ltd.

K number K242547

View details →

BZD 2025-01-15

Respiration Data Management Software (PAP Link PC)

Applicant BMC Medical Co., Ltd.

K number K242935

View details →

BZD 2024-12-31

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)

Applicant Genadyne Biotechnologies, Inc.

K number K243225

View details →

BZD 2024-10-18

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask

Applicant Sleepnet Corporation

K number K241830

View details →

BZD 2024-09-27

EasyCare Tx 2

Applicant Resmed Corp

K number K241939

View details →

BZD 2024-09-26

myAir

Applicant Resmed Corp

K number K241216

View details →

BZD 2024-09-24

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

Applicant Resmed Pty Ltd (Registration Number: 3004604967)

K number K234134

View details →

BZD 2024-08-23

Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)

Applicant Fisher and Paykel Healthcare Limited

K number K233829

View details →

BZD 2024-07-31

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask

Applicant Philips Respironics

K number K233555

View details →

BZD 2024-07-10

Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask

Applicant Sleepnet Corporation

K number K241661

View details →

BZD 2024-07-02

DELTAWAVE Nasal Pillows System

Applicant Remsleep Holdings

K number K233415

View details →

BZD 2024-06-15

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask

Applicant Sleepnet Corporation

K number K241469

View details →

BZD 2023-10-19

Oran Park Mask

Applicant Resmed Pty Ltd (Registration Number: 3004604967)

K number K230476

View details →

BZD 2023-07-28

Therapy Mask 3100 NC/SP

Applicant Respironics, Inc.

K number K231313

View details →

BZD 2023-07-06

Whitsundays Mask System

Applicant Resmed Pty Ltd (Registration Number: 3004604967)

K number K223747

View details →

BZD 2023-06-29

F&P 950 Accessory Breathing Circuit Kits

Applicant Fisher & Paykel Healthcare, Ltd.

K number K221436

View details →

BZD 2023-05-17

F&P Solo Mask Range

Applicant Fisher & Paykel Healthcare, Ltd.

K number K223696

View details →

BZD 2022-03-25

Luna G3 BPAP System

Applicant 3B Medical, Inc.

K number K212263

View details →

BZD 2022-03-18

F&P Evora Full Face Mask

Applicant Fisher & Paykel Healthcare, Ltd.

K number K212371

View details →

BZD 2022-03-09

Auto CPAP System

Applicant BMC Medical Co., Ltd.

K number K211155

View details →

BZD 2022-01-10

iQ 2 Nasal Mask, Phantom 2 Nasal Mask

Applicant Sleepnet Corporation

K number K211274

View details →

BZD 2021-08-24

DreamWear Silicone Pillows Mask

Applicant Respironics, Inc.

K number K210844

View details →

BZD 2021-07-12

Magneto Nasal Mask

Applicant Respironics, Inc.

K number K210386

View details →

BZD 2021-07-02

Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask

Applicant Suzhou Yuyue Medical Technology Co., Ltd.

K number K203347

View details →

BZD 2021-04-30

Innova Nasal Non-Vented Mask

Applicant Sleepnet Corporation

K number K203601

View details →

BZD 2021-01-29

Luna® G3 BPAP 25A

Applicant 3B Medical, Inc.

K number K201620

View details →

BZD 2021-01-17

Galapogos

Applicant Resmed Corp

K number K200565

View details →

BZD 2020-12-18

S10 Kirra

Applicant Resmed Pty , Ltd.

K number K203126

View details →

BZD 2020-11-25

SysMed S/T

Applicant Sysmed (China) Co., Ltd.

K number K192177

View details →

BZD 2020-10-29

WiZARD 510 Nasal Mask

Applicant Apex Medical Corp.

K number K193206

View details →

BZD 2020-09-25

Ventilator, Non-continuous (Respirator)

Applicant Respironics, Inc.

K number K201439

View details →

BZD 2020-07-10

DreamStation 2 System, DreamStation 2 Advanced System

Applicant Respironics, Inc.

K number K200480

View details →

BZD 2020-06-02

F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model

Applicant Fisher & Paykel Healthcare, Ltd.

K number K200089

View details →

BZD 2019-10-18

Care Orchestrator Essence

Applicant Respironics, Inc.

K number K183226

View details →

BZD 2019-10-11

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)

Applicant Fisher & Paykel Healthcare, Ltd.

K number K190713

View details →

BZD 2019-07-05

Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask

Applicant Sleepnet Corporation

K number K190254

View details →

BZD 2019-05-17

WiZARD 310/320 Series CPAP Mask

Applicant Apex Medical Corp.

K number K182394

View details →

BZD 2019-05-07

Moore Park Mask

Applicant Resmed, Ltd.

K number K183512

View details →

BZD 2019-01-04

Care Orchestrator

Applicant Respironics, Inc.

K number K181053

View details →

BZD 2018-11-30

Transcend 365 miniCPAP System

Applicant Somnetics International, Inc.

K number K180388

View details →

BZD 2018-08-08

F&P SleepStyle

Applicant Fisher & Paykel Healthcare, Ltd.

K number K173193

View details →

BZD 2018-06-15

Scone Mask

Applicant Resmed, Ltd.

K number K180497

View details →

BZD 2018-03-30

Bleep DreamPort

Applicant Snapcpap

K number K172335

View details →

BZD 2018-01-03

AirFit F20

Applicant Resmed, Ltd.

K number K170924

View details →

BZD 2017-09-28

AirFit N20

Applicant Resmed, Ltd.

K number K171212

View details →

BZD 2017-09-05

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

Applicant Bmc Medical., Ltd.

K number K163464

View details →

BZD 2017-03-15

SleepWeaver 3D Nasal Mask

Applicant Circadiance, LLC

K number K162905

View details →

BZD 2017-01-24

F&P InfoSmart

Applicant Fisher & Paykel Healthcare, Ltd.

K number K161686

View details →

BZD 2017-01-18

F&P Brevida™ Nasal Pillows Mask

Applicant Fisher & Paykel Healthcare, Ltd.

K number K161412

View details →

BZD 2016-12-15

Menai System

Applicant Resmed, Ltd.

K number K160836

View details →

BZD 2016-11-17

AirFit N20

Applicant Resmed, Ltd.

K number K161978

View details →

BZD 2016-11-10

iCodeConnect

Applicant 3B Medical, Inc.

K number K160127

View details →

BZD 2016-09-20

F&P Eson 2 Nasal Mask

Applicant Fisher & Paykel Healthcare Limited

K number K153505

View details →

BZD 2016-09-09

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV

Applicant Resmed, Ltd.

K number K160822

View details →

BZD 2016-09-08

Luna CPAP and Auto CPAP System

Applicant 3B Medical, Inc.

K number K153387

View details →

BZD 2016-05-13

AirFit F20

Applicant Resmed, Ltd.

K number K153563

View details →

BZD 2016-05-02

AirFit N20

Applicant Resmed, Ltd.

K number K153673

View details →

BZD 2016-04-15

Simple T Pediatric Nasal Mask

Applicant Respironics, Inc.

K number K151120

View details →

BZD 2016-04-05

SleepWeaver Advance Pediatric Nasal CPAP Mask

Applicant Circadiance, LLC

K number K151683

View details →

BZD 2016-01-21

DeVilbiss DV6WM Wireless Modem

Applicant Devilbiss Healthcare, LLC

K number K152810

View details →

BZD 2016-01-08

Sapphire

Applicant Respironics, Inc.

K number K152356

View details →

BZD 2013-12-23

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

Applicant 3B Medical, Inc.

K number K131901

View details →

BZD 2013-12-20

AIRFIT N10

Applicant Resmed, Ltd.

K number K132887

View details →

BZD 2013-12-06

3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP

Applicant 3B Medical, Inc.

K number K132967

View details →

BZD 2013-12-06

K SERIES CPAP SYSTEMS

Applicant Curative Medical, Inc.

K number K131702

View details →

BZD 2013-11-20

BRONCHOSCOPY ELBOW

Applicant Respironics, Inc.

K number K132168

View details →

BZD 2013-10-21

SWIFT AIR

Applicant Resmed, Ltd.

K number K132013

View details →

BZD 2013-10-18

REMSTAR AUTO A-FLEX HT

Applicant Respironics, Inc.

K number K131982

View details →

BZD 2013-10-17

TRANSCEND AUTO

Applicant Somnetics International, Inc.

K number K132127

View details →

BZD 2013-10-16

NASAL COMFORT FREEDOM

Applicant Lakeview Sleep Center

K number K130686

View details →

BZD 2013-10-11

SEATTLE - PAP

Applicant Seattle Childrens Hospital

K number K131502

View details →

BZD 2013-09-27

BESTFIT2 NASAL MASK

Applicant Curative Medical, Inc.

K number K130663

View details →

BZD 2013-08-22

3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS

Applicant 3B Medical, Inc.

K number K131707

View details →

BZD 2013-06-06

WIZARD 230 NASAL PILOW MASK

Applicant Apex Medical Corp.

K number K121642

View details →

BZD 2013-06-05

F&P SIMPLUS FULL FACE MASK

Applicant Fisher & Paykel Healthcare Limited

K number K130328

View details →

BZD 2013-05-24

SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK

Applicant Circadiance, LLC

K number K130481

View details →

BZD 2013-05-21

REMSTAR SE

Applicant Respironics, Inc.

K number K130077

View details →

BZD 2013-05-17

BREATHE CPAP SYSTEM

Applicant Breathe Technologies, Inc.

K number K130037

View details →

BZD 2013-03-29

SWIFT FX NANO

Applicant Resmed, Ltd.

K number K123789

View details →

BZD 2013-03-14

FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS

Applicant Intersurgical Incorporated

K number K121747

View details →

BZD 2013-03-13

K SERIES CPAP SYSTEMS

Applicant Curative Medical, Inc.

K number K123897

View details →

BZD 2013-03-06

KANGAROO NASAL MASK

Applicant Respironics, Inc.

K number K122847

View details →

BZD 2013-02-27

QUATTRO AIR

Applicant Resmed, Ltd.

K number K123979

View details →

BZD 2013-02-22

ZI BLOWER

Applicant Deshum Medical

K number K121374

View details →

BZD 2012-12-06

APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720

Applicant Apex Medical Corp.

K number K112079

View details →

BZD 2012-11-30

HARD SHELL VENTED NASAL MASK

Applicant Sleepnet Corporation

K number K121321

View details →