Ventilator, Continuous, Facility Use

K number K253647

CBK 2026-04-14

Inbentus Versatile

Applicant Iconic Solutions by Murcia, SL

K number K252663

CBK 2026-03-12

VPAP Pediatric Face Mask

Applicant Hsiner Co., Ltd.

K number K251888

CBK 2025-12-19

Vivo 45 LS

Applicant Oconnell Regulatory Consultants, Inc.

K number K232365

CBK 2025-09-10

F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full

Applicant Fisher & Paykel Healthcare, Ltd.

K number K252173

CBK 2025-08-28

SV600, SV800 Ventilator

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K243767

CBK 2025-05-08

AVEA disposable expiratory filter/water trap (11790)

Applicant Telesair, Inc.

K number K251133

CBK 2024-12-30

AF531 Oro-Nasal SE Face Mask

Applicant Respironics, Inc.

K number K243394

CBK 2024-12-13

731 Series Ventilator

Applicant ZOLL Medical Corporation

K number K233486

CBK 2024-12-02

Ventoux VC2; Ventoux VC3

K number K223120

CBK 2024-11-13

RESPOND(R) Ventilator

Applicant Corvent Medical, Inc.

K number K241135

CBK 2024-08-28

Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask

Applicant Sleepnet Corporation

K number K241943

CBK 2024-08-14

Family of DIMAR DMAX NIV masks

Applicant Dimar S.P.A.

K number K232836

CBK 2024-08-13

VM-2000

Applicant Ventis Medical, Inc.

K number K240807

CBK 2024-06-27

Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask

Applicant Sleepnet Corporation

K number K241520

CBK 2024-03-01

Nihon Kohden NKV-550 Series Ventilator System

Applicant Nihon Kohden Orangemed, LLC

K number K231778

CBK 2023-07-20

Panther 5

Applicant Origin Medical Devices

K number K213098

CBK 2023-06-16

Mindray SV600 Ventilator, Mindray SV800 Ventilator

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K220107

CBK 2023-05-31

Nihon Kohden NKV-440 Ventilator System

Applicant Nihon Kohden Orangemed, Inc.

K number K222644

CBK 2023-05-16

Babylog VN800, Babylog VN600

K number K222207

CBK 2023-05-16

Evita V800, Evita V600

K number K222024

CBK 2021-11-10

LTV2 Series Ventilators

Applicant Vyaire Medical, Inc.

K number K201082

CBK 2021-11-04

CARESCAPE R860

Applicant Datex-Ohmeda, Inc.

K number K210384

CBK 2021-04-20

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

Applicant Maquet Critical Care AB

K number K201874

CBK 2021-04-14

F&P Visairo NIV Mask Range

Applicant Fisher & Paykel Healthcare, Ltd.

K number K203449

CBK 2021-02-05

HAMILTON-C3

Applicant Hamilton Medical AG

K number K201306

CBK 2021-01-29

Ventway Sparrow

Applicant Inovytech Medical Solutions , Ltd.

K number K202970

CBK 2020-12-11

Hamilton-C6

Applicant Hamilton Medical AG

K number K201658

CBK 2020-11-20

Puritan Bennett 980 Series Ventilator System

Applicant Covidien, LLC

K number K193056

CBK 2020-06-18

Servo-air 4.0 Ventilator System

Applicant Maquet Critica Care AB

K number K192604

CBK 2020-05-04

Hamilton-G5

Applicant Hamilton Medical AG

K number K193228

CBK 2020-01-10

Nihon Kohden NKV-550 Series Ventilator System

Applicant Nihon Kohden Orangemed, Inc.

K number K192307

CBK 2019-09-13

Bellavista

Applicant Imtmedical AG

K number K183364

CBK 2019-08-02

HAMILTON-T1, HAMILTON-C1

Applicant Hamilton Medical AG

K number K181216

CBK 2019-07-30

Hamilton-G5

Applicant Hamiton Medical AG

K number K180295

CBK 2019-07-26

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

Applicant Sleepnet Corporation

K number K190533

CBK 2019-07-18

Trilogy Evo Universal

Applicant Respironics, Inc.

K number K181170

CBK 2019-07-18

Trilogy Evo

Applicant Respironics, Inc.

K number K181166

CBK 2019-03-19

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

Applicant Maquet Critical Care AB

K number K180098

CBK 2019-01-17

Savina 300

Applicant Dragerwerk AG & CO Kgaa

K number K180779

CBK 2018-12-07

Nihon Kohden NKV-550 Series Ventilator System

Applicant Nihon Kohden Orangemed, Inc.

K number K181695

CBK 2018-07-20

TV-100

Applicant Bio-Med Devices, Inc.

K number K173973

CBK 2018-04-26

Astral 100/150

Applicant Resmed, Ltd.

K number K172875

CBK 2018-01-25

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

Applicant Fisher and Paykel Healthcare Limited

K number K173060

CBK 2017-10-27

Puritan Bennett 980 Ventilator System

Applicant Covidien

K number K162738

CBK 2017-08-11

Breathe Technologies Life2000™ Ventilation System

Applicant Breathe Technologies

K number K170037

CBK 2017-08-02

731 Series Ventilators

Applicant ZOLL Medical Corporation

K number K162832

CBK 2017-07-31

bellavista 1000

Applicant Imtmedical AG

K number K163127

CBK 2017-04-27

HAMILTON-C3

Applicant Hamilton Medical AG

K number K161450

CBK 2017-04-07

VOCSN Unified Respiratory System

Applicant Ventec Life Systems, Inc.

K number K162877

CBK 2016-09-06

HAMILTON-MR1

Applicant Hamilton Medical AG

K number K153046

CBK 2016-05-13

Astral 100/150

Applicant Resmed, Ltd.

K number K152068

CBK 2016-03-30

Flight 60 Ventilator

K number K143035

CBK 2016-03-29

Puritan Bennett 840 Series Ventilator System

Applicant Covidien LP

K number K151252

CBK 2013-11-20

HAMILTON-MR1

Applicant Hamilton Medical AG

K number K122438

CBK 2013-10-29

INSPIRATION VENTILATOR SYSTEM 5I/7I

Applicant eVent Medical, Ltd.

K number K130178

CBK 2013-10-09

HAMILTON-G5

Applicant Hamilton Medical AG

K number K131774

CBK 2013-06-06

CRITICAL CARE VENTILATOR

Applicant Oricare, Inc.

K number K120931

CBK 2013-03-26

VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1

Applicant Pan-America Hyperbarics, Inc.

K number K122560

CBK 2012-12-21

HAMILTON-C3

Applicant Hamilton Medical AG

K number K123637

CBK 2012-12-18

EVOLUTION 3E VENTILATOR

Applicant Event Medical, Inc.

K number K113743

CBK 2012-12-11

QUARK SERIES

Applicant Cosmed Srl

K number K120146

CBK 2012-11-16

HAMILTON-C2

Applicant Hamilton Medical AG

K number K121225

CBK 2012-11-09

NEWPORT AURA VENTILATOR

Applicant Newport Medical Instruments, Inc.

K number K121891

CBK 2012-10-11

PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY

Applicant Airon Corporation

K number K121379

CBK 2012-07-10

PERFORMAX PEDIATRIC SE TOTAL FACE MASK

Applicant Respironics, Inc.

K number K120639

CBK 2012-07-06

FLIGHT 60 VENTILATOR

K number K120726

CBK 2012-06-15

IVENT101

Applicant Versamed Medical Systems , Ltd.

K number K112754

CBK 2012-06-11

BLEASE700/900 SERIES VENTILATORS

Applicant Spacelabs Healthcare

K number K112729

CBK 2012-05-30

HAMILTON-C1

Applicant Hamilton Medical AG

K number K120574

CBK 2012-04-03

HAMILTON-T1

Applicant Hamilton Medical AG

K number K120670

CBK 2012-03-22

SPACELABS ARKON ANESTHESIA WORKSTATION

Applicant Spacelabs Healthcare

K number K113051

CBK 2012-02-16

UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR

Applicant Impact Instrumentation, Inc.

K number K111473

CBK 2012-02-09

HAMILTON-TC1

Applicant Hamilton Medical AG

K number K112006

CBK 2012-01-27

NEUMOVENT GRAPHNET

Applicant Tecme S.A.

K number K111595

CBK 2012-01-13

V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE

Applicant Respironics California, Inc.

K number K110083

CBK 2011-12-01

NEWPORT HT70 VENTILATOR

Applicant Newport Medical Instruments, Inc.

K number K111146

CBK 2011-11-23

HAMILTON-G5

Applicant Hamilton Medical AG

K number K103803

CBK 2011-10-31

FLIGHT 60 VENTILATOR

K number K111683

CBK 2011-10-14

TRILOGY SERIES VENTILATOR WITH OXIMETRY

Applicant Respironics, Inc.

K number K111610

CBK 2011-10-06

OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE

Applicant Draeger Medical Systems, Inc.

K number K103625

CBK 2011-09-09

ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000

Applicant Datex-Ohmeda

K number K111116

CBK 2011-08-19

V200 INTELLI-TRAK OPTION

Applicant Respironics California, Inc.

K number K110795

CBK 2011-08-12

NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202

Applicant Hsiner Co., Ltd.

K number K102120

CBK 2011-05-12

AVEA VENTILATOR

Applicant Care Fusion

K number K103211

CBK 2011-04-07

UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR

Applicant Impact Instrumentation, Inc.

K number K103318

CBK 2011-03-02

SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION

Applicant Spacelabs Healthcare, Ltd.

K number K101850

CBK 2011-01-26

MODEL LTV 1100 VENTILATOR

Applicant Care Fusion

K number K101643

CBK 2011-01-21

HAMILTON-C2

Applicant Hamilton Medical AG

K number K102775

CBK 2010-12-22

V200 VENTILATOR

Applicant Respironics California, Inc.

K number K102054

CBK 2010-12-07

NEUMOVENT GRAPHNET MODEL 3179L1V

Applicant Tecme S.A.

K number K101401

CBK 2010-09-16

ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK

Applicant Respironics, Inc.

K number K101129

CBK 2010-09-08

NEWPORT E360 VENTILATOR

Applicant Newport Medical Instruments, Inc.

K number K101803

CBK 2010-08-20

FLIGHT 60 VENTILATOR, MODEL F-60

Applicant Flight Medical , Ltd.

K number K100753

CBK 2010-05-12

TRILOGY 202 VENTILATOR

Applicant Respironics, Inc.

K number K093905

CBK 2010-05-11

VELA VENTILATOR

Applicant Cardinal Health 207, Inc.

K number K093094

CBK 2010-05-03

ENGSTROM CARESTATION, ENGSTROM PRO

Applicant Datex-Ohmeda Inc., A Division of Instrumentarium C

K number K093886

CBK 2010-04-05

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE

Applicant Drager Medical AG & Co. Kgaa

K number K093632

CBK 2010-03-30

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE

K number K093633

CBK 2010-03-11

840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION

Applicant Covidien, Formerly Nellcor Puritan Bennett, Inc.

K number K092847