CBK · Ventilator, Continuous, Facility Use
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | CBK |
|---|---|
| Device Name | Ventilator, Continuous, Facility Use |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Cleared Devices (504)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | Apr 14, 2026 | SESE |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | Mar 12, 2026 | SESE |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | Dec 19, 2025 | SESE |
| K252173 | 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 | Fisher & Paykel Healthcare, Ltd. | Sep 10, 2025 | SESE |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Aug 28, 2025 | SESE |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | May 8, 2025 | SESE |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | Dec 30, 2024 | SESE |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | Dec 13, 2024 | SESE |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | Dec 2, 2024 | SESE |
| K241135 | RESPOND(R) Ventilator | Corvent Medical, Inc. | Nov 13, 2024 | SESE |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Sleepnet Corporation | Aug 28, 2024 | SESE |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | Aug 14, 2024 | SESE |
| K240807 | VM-2000 | Ventis Medical, Inc. | Aug 13, 2024 | SESE |
| K241520 | 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 | Sleepnet Corporation | Jun 27, 2024 | SESE |
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | Mar 1, 2024 | SESE |
| K213098 | Panther 5 | Origin Medical Devices | Jul 20, 2023 | SESE |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jun 16, 2023 | SESE |
| K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | May 31, 2023 | SESE |
| K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | May 16, 2023 | SESE |
| K222024 | Evita V800, Evita V600 | Draegerwerk AG & CO Kgaa | May 16, 2023 | SESE |
| K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | Nov 10, 2021 | SESE |
| K210384 | CARESCAPE R860 | Datex-Ohmeda, Inc. | Nov 4, 2021 | SESE |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | Maquet Critical Care AB | Apr 20, 2021 | SESE |
| K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | Apr 14, 2021 | SESE |
| K201306 | HAMILTON-C3 | Hamilton Medical AG | Feb 5, 2021 | SESE |
| K202970 | Ventway Sparrow | Inovytech Medical Solutions , Ltd. | Jan 29, 2021 | SESE |
| K201658 | Hamilton-C6 | Hamilton Medical AG | Dec 11, 2020 | SESE |
| K193056 | Puritan Bennett 980 Series Ventilator System | Covidien, LLC | Nov 20, 2020 | SESE |
| K192604 | Servo-air 4.0 Ventilator System | Maquet Critica Care AB | Jun 18, 2020 | SESE |
| K193228 | Hamilton-G5 | Hamilton Medical AG | May 4, 2020 | SESE |
| K192307 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | Jan 10, 2020 | SESE |
| K183364 | Bellavista | Imtmedical AG | Sep 13, 2019 | SESE |
| K181216 | HAMILTON-T1, HAMILTON-C1 | Hamilton Medical AG | Aug 2, 2019 | SESE |
| K180295 | Hamilton-G5 | Hamiton Medical AG | Jul 30, 2019 | SESE |
| K190533 | 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 | Sleepnet Corporation | Jul 26, 2019 | SESE |
| K181170 | Trilogy Evo Universal | Respironics, Inc. | Jul 18, 2019 | SESE |
| K181166 | Trilogy Evo | Respironics, Inc. | Jul 18, 2019 | SESE |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Maquet Critical Care AB | Mar 19, 2019 | SESE |
| K180779 | Savina 300 | Dragerwerk AG & CO Kgaa | Jan 17, 2019 | SESE |
| K181695 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | Dec 7, 2018 | SESE |
| K173973 | TV-100 | Bio-Med Devices, Inc. | Jul 20, 2018 | SESE |
| K172875 | Astral 100/150 | Resmed, Ltd. | Apr 26, 2018 | SESE |
| K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | Fisher and Paykel Healthcare Limited | Jan 25, 2018 | SESE |
| K162738 | Puritan Bennett 980 Ventilator System | Covidien | Oct 27, 2017 | SESE |
| K170037 | Breathe Technologies Life2000 Ventilation System | Breathe Technologies | Aug 11, 2017 | SESE |
| K162832 | 731 Series Ventilators | ZOLL Medical Corporation | Aug 2, 2017 | SESE |
| K163127 | bellavista 1000 | Imtmedical AG | Jul 31, 2017 | SESE |
| K161450 | HAMILTON-C3 | Hamilton Medical AG | Apr 27, 2017 | SESE |
| K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | Apr 7, 2017 | SESE |
| K153046 | HAMILTON-MR1 | Hamilton Medical AG | Sep 6, 2016 | SESE |
| K152068 | Astral 100/150 | Resmed, Ltd. | May 13, 2016 | SESE |
| K143035 | Flight 60 Ventilator | Flight Medical Innovations , Ltd. | Mar 30, 2016 | SESE |
| K151252 | Puritan Bennett 840 Series Ventilator System | Covidien LP | Mar 29, 2016 | SESE |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Maquet Critical Care AB | Dec 21, 2015 | SESE |
| K151901 | AirView | Resmed, Ltd. | Nov 5, 2015 | SESE |
| K150638 | AF541 SE Full Face Mask | Respironics, Inc. | Sep 18, 2015 | SESE |
| K140939 | HAMILTON-T1,HAMILTON-C1 | Hamilton Medical AG | Sep 2, 2015 | SESE |
| K142679 | CARESCAPE R860 | Datex-Ohmeda, Inc. | Jun 12, 2015 | SESE |
| K141943 | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM | Breathe Technologies | Jun 12, 2015 | SESE |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Datex-Ohmeda, Inc. | Feb 3, 2015 | SESE |
| K121886 | SAVINA 300 SAVINA 300, COUNTRY VARIANTS | Draeger Medical GmbH | Aug 8, 2014 | SESE |
| K123149 | SERVO-I VENTILATOR SYSTEM | Maquet Critical Care AB | Jun 20, 2014 | SESE |
| K133868 | ASTRAL VENTILATOR | Resmed, Ltd. | Jun 4, 2014 | SESE |
| K130171 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | Apr 8, 2014 | SESE |
| K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM | Covidien | Feb 24, 2014 | SESE |
| K122438 | HAMILTON-MR1 | Hamilton Medical AG | Nov 20, 2013 | SESE |
| K130178 | INSPIRATION VENTILATOR SYSTEM 5I/7I | eVent Medical, Ltd. | Oct 29, 2013 | SESE |
| K131774 | HAMILTON-G5 | Hamilton Medical AG | Oct 9, 2013 | SESE |
| K120931 | CRITICAL CARE VENTILATOR | Oricare, Inc. | Jun 6, 2013 | SESE |
| K122560 | VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 | Pan-America Hyperbarics, Inc. | Mar 26, 2013 | SESE |
| K123637 | HAMILTON-C3 | Hamilton Medical AG | Dec 21, 2012 | SESE |
| K113743 | EVOLUTION 3E VENTILATOR | Event Medical, Inc. | Dec 18, 2012 | SESE |
| K120146 | QUARK SERIES | Cosmed Srl | Dec 11, 2012 | SESE |
| K121225 | HAMILTON-C2 | Hamilton Medical AG | Nov 16, 2012 | SESE |
| K121891 | NEWPORT AURA VENTILATOR | Newport Medical Instruments, Inc. | Nov 9, 2012 | SESE |
| K121379 | PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY | Airon Corporation | Oct 11, 2012 | SESE |
| K120639 | PERFORMAX PEDIATRIC SE TOTAL FACE MASK | Respironics, Inc. | Jul 10, 2012 | SESE |
| K120726 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | Jul 6, 2012 | SESE |
| K112754 | IVENT101 | Versamed Medical Systems , Ltd. | Jun 15, 2012 | SESE |
| K112729 | BLEASE700/900 SERIES VENTILATORS | Spacelabs Healthcare | Jun 11, 2012 | SESE |
| K120574 | HAMILTON-C1 | Hamilton Medical AG | May 30, 2012 | SESE |
| K120670 | HAMILTON-T1 | Hamilton Medical AG | Apr 3, 2012 | SESE |
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION | Spacelabs Healthcare | Mar 22, 2012 | SESE |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR | Impact Instrumentation, Inc. | Feb 16, 2012 | SESE |
| K112006 | HAMILTON-TC1 | Hamilton Medical AG | Feb 9, 2012 | SESE |
| K111595 | NEUMOVENT GRAPHNET | Tecme S.A. | Jan 27, 2012 | SESE |
| K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE | Respironics California, Inc. | Jan 13, 2012 | SESE |
| K111146 | NEWPORT HT70 VENTILATOR | Newport Medical Instruments, Inc. | Dec 1, 2011 | SESE |
| K103803 | HAMILTON-G5 | Hamilton Medical AG | Nov 23, 2011 | SESE |
| K111683 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | Oct 31, 2011 | SESE |
| K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY | Respironics, Inc. | Oct 14, 2011 | SESE |
| K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE | Draeger Medical Systems, Inc. | Oct 6, 2011 | SESE |
| K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 | Datex-Ohmeda | Sep 9, 2011 | SESE |
| K110795 | V200 INTELLI-TRAK OPTION | Respironics California, Inc. | Aug 19, 2011 | SESE |
| K102120 | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 | Hsiner Co., Ltd. | Aug 12, 2011 | SESE |
| K103211 | AVEA VENTILATOR | Care Fusion | May 12, 2011 | SESE |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR | Impact Instrumentation, Inc. | Apr 7, 2011 | SESE |
| K101850 | SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION | Spacelabs Healthcare, Ltd. | Mar 2, 2011 | SESE |
| K101643 | MODEL LTV 1100 VENTILATOR | Care Fusion | Jan 26, 2011 | SESE |
| K102775 | HAMILTON-C2 | Hamilton Medical AG | Jan 21, 2011 | SESE |
| K102054 | V200 VENTILATOR | Respironics California, Inc. | Dec 22, 2010 | SESE |
| K101401 | NEUMOVENT GRAPHNET MODEL 3179L1V | Tecme S.A. | Dec 7, 2010 | SESE |
| K101129 | ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK | Respironics, Inc. | Sep 16, 2010 | SESE |
| K101803 | NEWPORT E360 VENTILATOR | Newport Medical Instruments, Inc. | Sep 8, 2010 | SESE |
| K100753 | FLIGHT 60 VENTILATOR, MODEL F-60 | Flight Medical , Ltd. | Aug 20, 2010 | SESE |
| K093905 | TRILOGY 202 VENTILATOR | Respironics, Inc. | May 12, 2010 | SESE |
| K093094 | VELA VENTILATOR | Cardinal Health 207, Inc. | May 11, 2010 | SESE |
| K093886 | ENGSTROM CARESTATION, ENGSTROM PRO | Datex-Ohmeda Inc., A Division of Instrumentarium C | May 3, 2010 | SESE |
| K093632 | INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE | Drager Medical AG & Co. Kgaa | Apr 5, 2010 | SESE |
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | Draegerwerk AG & CO Kgaa | Mar 30, 2010 | SESE |
| K092847 | 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION | Covidien, Formerly Nellcor Puritan Bennett, Inc. | Mar 11, 2010 | SESE |
| K092148 | HAMILTON-C2 | Hamilton Medical AG | Mar 4, 2010 | SESE |
| K093416 | TRILOGY 200 VENTILATOR | Respironics, Inc. | Jan 29, 2010 | SESE |
| K092263 | ENDURAVENT-5 VENTILATOR | Providence Global Medical, Inc. | Jan 21, 2010 | SESE |
| K092648 | RESPIRONICS PERFORMAX SE TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | Dec 18, 2009 | SESE |
| K092264 | ATLANTIS HYPERBARIC CHAMBER VENTILATOR | Providence Global Medical, Inc. | Dec 17, 2009 | SESE |
| K092135 | MODIFICATION TO IVENT 101 | Versamed Medical Systems , Ltd. | Nov 23, 2009 | SESE |
| K090888 | NEWPORT HT70 FAMILY OF VENTILATORS | Newport Medical Instruments, Inc. | Nov 18, 2009 | SESE |
| K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ | Impact Instrumentation, Inc. | Aug 13, 2009 | SESE |
| K090468 | HAMILTON-C2 | Hamilton Medical AG | Jun 15, 2009 | SESE |
| K083693 | PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | Apr 2, 2009 | SESE |
| K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | Pulmonetic Systems, Inc. | Mar 18, 2009 | SESE |
| K081845 | IVENT101 | Versamed Medical Systems, Inc. | Mar 16, 2009 | SESE |
| K083526 | TRILOGY 100 VENTILATOR | Respironics Inc., Sleep & Home Respiratory Group | Mar 13, 2009 | SESE |
| K083122 | HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 | Fisher & Paykel Healthcare, Ltd. | Mar 4, 2009 | SESE |
| K082351 | NEPTUNE HYPERBARIC VENTILATOR | Level-5, Inc. | Jan 2, 2009 | SESE |
| K083050 | EVITE XL | Draeger Medical AG & Co. KG | Dec 29, 2008 | SESE |
| K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM | Newport Medical Instruments, Inc. | Dec 16, 2008 | SESE |
| K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV | Impact Instrumentation, Inc. | Dec 10, 2008 | SESE |
| K082600 | OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) | Draeger Medical B.V. | Nov 26, 2008 | SESE |
| K082966 | PB 540 VENTILATOR | Covidien, Formerly Nellcor Puritan Bennett, Inc. | Oct 31, 2008 | SESE |
| K072926 | HELONTIX VENT | Linde Gas Therapeutics | Oct 15, 2008 | SESE |
| K081670 | THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK | Cardinal Health 207, Inc. | Oct 9, 2008 | SESE |
| K081842 | ENGSTROM CARESTATION, ENGSTROM PRO | Datex-Ohmeda, Inc. | Oct 3, 2008 | SESE |
| K081521 | MODIFICATION TO HAMILTON-G5 | Hamilton Medical AG | Sep 25, 2008 | SESE |
| K081743 | CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS | Draeger Medical AG & Co. KG | Sep 22, 2008 | SESE |
| K081837 | AVEA VENTILATOR | Cardinal Health 207, Inc. | Aug 13, 2008 | SESE |
| K080181 | MODIFICATION TO GALILEO GOLD | Hamilton Medical AG | Jun 24, 2008 | SESE |
| K073179 | SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 | Maquet Critical Care AB | Jun 9, 2008 | SESE |
| K073694 | IVENT 2001 MRI CONDITIONAL | Versamed Medical Systems, Inc. | May 30, 2008 | SESE |
| K072885 | CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 | Draeger Medical AG & Co. KG | Apr 7, 2008 | SESE |
| K072412 | OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 | Drager Medical AG & Co. Kgaa | Feb 6, 2008 | SESE |
| K073069 | MODIFICATION TO AVEA VENTILATOR | Viasys Respiratory Care, Inc. | Jan 25, 2008 | SESE |
| K072590 | INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM | Event Medical, Inc. | Jan 4, 2008 | SESE |
| K072588 | PERFORMAX SE TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | Dec 18, 2007 | SESE |
| K070899 | PURITAN BENNETT LEGENDAIR XL2 | Nellcor Puritan Bennett | Dec 13, 2007 | SESE |
| K072450 | ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 | Respironics California, Inc. | Dec 12, 2007 | SESE |
| K070513 | HAMILTON-G5 | Hamilton Medical AG | Nov 26, 2007 | SESE |
| K071194 | RAPHAEL COLOR ASV VENTILATOR | Hamilton Medical AG | Oct 18, 2007 | SESE |
| K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 | Pulmonetic Systems, Inc. | Aug 1, 2007 | SESE |
| K071212 | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 | Respironics California, Inc. | Jul 30, 2007 | SESE |
| K063806 | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED | Sleepnet Corporation | May 17, 2007 | SESE |
| K063650 | VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 | Puritan Bennett Corp. | Feb 15, 2007 | SESE |
| K063404 | SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 | Maquet Critical Care AB | Feb 15, 2007 | SESE |
| K062793 | SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION | Maquet Critical Care AB | Feb 7, 2007 | SESE |
| K062710 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | Dec 8, 2006 | SESE |
| K062267 | OXYLOG 3000 | Drager Medical B.V. | Oct 31, 2006 | SESE |
| K062093 | AVEA VENTILATOR | Viasys Respiratory Care, Inc. | Sep 20, 2006 | SESE |
| K062019 | RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD | Innomed Technologies, Inc./Respcare, Inc. | Aug 17, 2006 | SESE |
| K061094 | NEWPORT E500 WAVE VENTILATOR | Newport Medical Instruments, Inc. | Jul 28, 2006 | SESE |
| K061090 | GALILEO GOLD ASV | Hamilton Medical AG | Jul 17, 2006 | SESE |
| K061627 | MODIFICATION TO I VENT 201 | Versamed Medical Systems, Inc. | Jun 29, 2006 | SESE |
| K060705 | CARINA HOME | Draeger Medical B.V. | Jun 14, 2006 | SESE |
| K060862 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | Jun 5, 2006 | SESE |
| K060647 | LTV 1200 VENTILATOR | Pulmonetic Systems, Inc. | May 25, 2006 | SESE |
| K060549 | AUTOMOBILE LIGHTER POWER CORD | Pulmonetic Systems, Inc. | May 4, 2006 | SESE |
| K053388 | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION | Puritan Bennett Corp. | Apr 4, 2006 | SESE |
| K053270 | IVENT 201 | Versamed Medical Systems, Inc. | Jan 27, 2006 | SESE |
| K053502 | NEWPORT E360 VENTILATOR | Newport Medical Instruments, Inc. | Jan 10, 2006 | SESE |
| K052863 | RAPHAEL COLOR | Hamilton Medical AG | Jan 6, 2006 | SESE |
| K051895 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | Sep 27, 2005 | SESE |
| K052554 | MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR | Versamed Medical Systems, Inc. | Sep 23, 2005 | SESE |
| K051222 | AV-S ANAESTHESIA VENTILATOR | Penlon Limited | Sep 23, 2005 | SESE |
| K051767 | LTV 1000 VENTILATOR | Pulmonetic Systems, Inc. | Jul 29, 2005 | SESE |
| K051550 | INSPIRATION VENTILATOR SYSTEM | eVent Medical, Ltd. | Jul 12, 2005 | SESE |
| K051263 | EVITAXL WITH OPTION SMARTCARE | Drager Medical AG & Co. Kgaa | Jul 12, 2005 | SESE |
| K051262 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 | Respironics California, Inc. | Jul 8, 2005 | SESE |
| K050860 | GE DATEX-OHMEDA CENTIVA/5 VENTILATOR | Datex-Ohmeda, Inc. | Jun 21, 2005 | SESE |
| K050597 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | Mar 25, 2005 | SESE |
| K043085 | MODIFICATION TO: PNEUTON VENTILATOR | Airon Corporation | Dec 20, 2004 | SESE |
| K042468 | IVENT 201 PORTABLE VENTILATOR | Versamed Medical Systems, Inc. | Nov 17, 2004 | SESE |
| K040574 | GALILEO GOLD | Hamilton Medical, Inc. | Oct 27, 2004 | SESE |
| K041775 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | Oct 26, 2004 | SESE |
| K032922 | CLARISSA INFANT NCPAP CANNULA | Airways Ltd., Inc. | Sep 22, 2004 | SESE |
| K041524 | GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM | Datex-Ohmeda, Inc. | Sep 20, 2004 | SESE |
| K041223 | MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E | Maquet Critical Care AB | Jul 29, 2004 | SESE |
| K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 | Respironics California, Inc. | Jun 18, 2004 | SESE |
| K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS | Pulmonetic Systems, Inc. | Jun 3, 2004 | SESE |
| K040642 | LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA | Draeget Medical AG & Co. Kgaa | Jun 2, 2004 | SESE |
| K040540 | MODIFICATION TO LTV 1000 VENTILATOR | Pulmonetic Systems, Inc. | Apr 29, 2004 | SESE |
| K032451 | BIRD TBIRD VELA VENTILATOR | Bird Products Corp. | Mar 17, 2004 | SESE |
| K040221 | SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E | Maquet Critical Care AB | Feb 20, 2004 | SESE |
| K030780 | NEWPORT E500 WAVE VENTILATOR | Newport Medical Instruments, Inc. | Jan 23, 2004 | SESE |
| K034040 | ESPRIT VENTILATOR, MODEL V1000 | Respironics, Inc. | Jan 21, 2004 | SESE |
| K030341 | MODIFICATION TO INSPIRATION VENTILATOR SYSTEM | eVent Medical, Ltd. | Jan 16, 2004 | SESE |
| K022679 | RAPHAEL | Hamilton Medical AG | Oct 22, 2003 | SESE |
| K032226 | LTV-1000 VENTILATOR | Pulmonetic Systems, Inc. | Oct 16, 2003 | SESE |
| K023366 | DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS | Datex-Ohmeda, Inc. | Oct 7, 2003 | SESE |
| K024344 | PNEUTON VENTILATOR | Airon Corporation | Jun 3, 2003 | SESE |
| K030515 | HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS | Hans Rudolph, Inc. | May 2, 2003 | SESE |
Top Applicants
- Puritan Bennett Corp. — 33 clearances
- Hamilton Medical AG — 25 clearances
- Bird Products Corp. — 21 clearances
- Newport Medical Instruments, Inc. — 17 clearances
- Siemens Elema AB — 15 clearances
