Atlas FDA

CBK

505 FDA 510(k) clearances · Product code

127 daysmedian time to decision
385 days90th percentile
505clearances measured

FDA profile

Official device name
Ventilator, Continuous, Facility Use
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5895
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 13,322 · 2022: 15,974 · 2023: 24,928 · 2024: 20,336 · 2025: 14,199 · 2026: 8,741
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Evita (V800); Evita (V600) (K253647)Draegerwerk AG & CO Kgaa2026-05-07
Inbentus Versatile (K252663)Iconic Solutions by Murcia, SL2026-04-14
VPAP Pediatric Face Mask (K251888)Hsiner Co., Ltd.2026-03-12
Vivo 45 LS (K232365)Oconnell Regulatory Consultants, Inc.2025-12-19
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 (K252173)Fisher & Paykel Healthcare, Ltd.2025-09-10
SV600, SV800 Ventilator (K243767)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2025-08-28
AVEA disposable expiratory filter/water trap (11790) (K251133)Telesair, Inc.2025-05-08
AF531 Oro-Nasal SE Face Mask (K243394)Respironics, Inc.2024-12-30
731 Series Ventilator (K233486)ZOLL Medical Corporation2024-12-13
Ventoux VC2; Ventoux VC3 (K223120)Flight Medical Innovations , Ltd.2024-12-02
RESPOND(R) Ventilator (K241135)Corvent Medical, Inc.2024-11-13
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask (K241943)Sleepnet Corporation2024-08-28
Family of DIMAR DMAX NIV masks (K232836)Dimar S.P.A.2024-08-14
VM-2000 (K240807)Ventis Medical, Inc.2024-08-13
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 (K241520)Sleepnet Corporation2024-06-27
Nihon Kohden NKV-550 Series Ventilator System (K231778)Nihon Kohden Orangemed, LLC2024-03-01
Panther 5 (K213098)Origin Medical Devices2023-07-20
Mindray SV600 Ventilator, Mindray SV800 Ventilator (K220107)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2023-06-16
Nihon Kohden NKV-440 Ventilator System (K222644)Nihon Kohden Orangemed, Inc.2023-05-31
Evita V800, Evita V600 (K222024)Draegerwerk AG & CO Kgaa2023-05-16
Babylog VN800, Babylog VN600 (K222207)Draegerwerk AG & CO Kgaa2023-05-16
LTV2 Series Ventilators (K201082)Vyaire Medical, Inc.2021-11-10
CARESCAPE R860 (K210384)Datex-Ohmeda, Inc.2021-11-04
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 (K201874)Maquet Critical Care AB2021-04-20
F&P Visairo NIV Mask Range (K203449)Fisher & Paykel Healthcare, Ltd.2021-04-14
HAMILTON-C3 (K201306)Hamilton Medical AG2021-02-05
Ventway Sparrow (K202970)Inovytech Medical Solutions , Ltd.2021-01-29
Hamilton-C6 (K201658)Hamilton Medical AG2020-12-11
Puritan Bennett 980 Series Ventilator System (K193056)Covidien, LLC2020-11-20
Servo-air 4.0 Ventilator System (K192604)Maquet Critica Care AB2020-06-18
Hamilton-G5 (K193228)Hamilton Medical AG2020-05-04
Nihon Kohden NKV-550 Series Ventilator System (K192307)Nihon Kohden Orangemed, Inc.2020-01-10
Bellavista (K183364)Imtmedical AG2019-09-13
HAMILTON-T1, HAMILTON-C1 (K181216)Hamilton Medical AG2019-08-02
Hamilton-G5 (K180295)Hamiton Medical AG2019-07-30
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 (K190533)Sleepnet Corporation2019-07-26
Trilogy Evo (K181166)Respironics, Inc.2019-07-18
Trilogy Evo Universal (K181170)Respironics, Inc.2019-07-18
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (K180098)Maquet Critical Care AB2019-03-19
Savina 300 (K180779)Dragerwerk AG & CO Kgaa2019-01-17
Nihon Kohden NKV-550 Series Ventilator System (K181695)Nihon Kohden Orangemed, Inc.2018-12-07
TV-100 (K173973)Bio-Med Devices, Inc.2018-07-20
Astral 100/150 (K172875)Resmed, Ltd.2018-04-26
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (K173060)Fisher and Paykel Healthcare Limited2018-01-25
Puritan Bennett 980 Ventilator System (K162738)Covidien2017-10-27
Breathe Technologies Life2000™ Ventilation System (K170037)Breathe Technologies2017-08-11
731 Series Ventilators (K162832)ZOLL Medical Corporation2017-08-02
bellavista 1000 (K163127)Imtmedical AG2017-07-31
HAMILTON-C3 (K161450)Hamilton Medical AG2017-04-27
VOCSN Unified Respiratory System (K162877)Ventec Life Systems, Inc.2017-04-07
HAMILTON-MR1 (K153046)Hamilton Medical AG2016-09-06
Astral 100/150 (K152068)Resmed, Ltd.2016-05-13
Flight 60 Ventilator (K143035)Flight Medical Innovations , Ltd.2016-03-30
Puritan Bennett 840 Series Ventilator System (K151252)Covidien LP2016-03-29
SERVO-U Ventilator System, SERVO-n Ventilator System (K151814)Maquet Critical Care AB2015-12-21
AirView (K151901)Resmed, Ltd.2015-11-05
AF541 SE Full Face Mask (K150638)Respironics, Inc.2015-09-18
HAMILTON-T1,HAMILTON-C1 (K140939)Hamilton Medical AG2015-09-02
CARESCAPE R860 (K142679)Datex-Ohmeda, Inc.2015-06-12
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM (K141943)Breathe Technologies2015-06-12
ENGSTROM CARESTATION, ENGSTROM PRO (K140575)Datex-Ohmeda, Inc.2015-02-03
SAVINA 300 SAVINA 300, COUNTRY VARIANTS (K121886)Draeger Medical GmbH2014-08-08
SERVO-I VENTILATOR SYSTEM (K123149)Maquet Critical Care AB2014-06-20
ASTRAL VENTILATOR (K133868)Resmed, Ltd.2014-06-04
FLIGHT 60 VENTILATOR (K130171)Flight Medical Innovations , Ltd.2014-04-08
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM (K131252)Covidien2014-02-24
HAMILTON-MR1 (K122438)Hamilton Medical AG2013-11-20
INSPIRATION VENTILATOR SYSTEM 5I/7I (K130178)eVent Medical, Ltd.2013-10-29
HAMILTON-G5 (K131774)Hamilton Medical AG2013-10-09
CRITICAL CARE VENTILATOR (K120931)Oricare, Inc.2013-06-06
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 (K122560)Pan-America Hyperbarics, Inc.2013-03-26
HAMILTON-C3 (K123637)Hamilton Medical AG2012-12-21
EVOLUTION 3E VENTILATOR (K113743)Event Medical, Inc.2012-12-18
QUARK SERIES (K120146)Cosmed Srl2012-12-11
HAMILTON-C2 (K121225)Hamilton Medical AG2012-11-16
NEWPORT AURA VENTILATOR (K121891)Newport Medical Instruments, Inc.2012-11-09
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY (K121379)Airon Corporation2012-10-11
PERFORMAX PEDIATRIC SE TOTAL FACE MASK (K120639)Respironics, Inc.2012-07-10
FLIGHT 60 VENTILATOR (K120726)Flight Medical Innovations , Ltd.2012-07-06
IVENT101 (K112754)Versamed Medical Systems , Ltd.2012-06-15
BLEASE700/900 SERIES VENTILATORS (K112729)Spacelabs Healthcare2012-06-11
HAMILTON-C1 (K120574)Hamilton Medical AG2012-05-30
HAMILTON-T1 (K120670)Hamilton Medical AG2012-04-03
SPACELABS ARKON ANESTHESIA WORKSTATION (K113051)Spacelabs Healthcare2012-03-22
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR (K111473)Impact Instrumentation, Inc.2012-02-16
HAMILTON-TC1 (K112006)Hamilton Medical AG2012-02-09
NEUMOVENT GRAPHNET (K111595)Tecme S.A.2012-01-27
V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE (K110083)Respironics California, Inc.2012-01-13
NEWPORT HT70 VENTILATOR (K111146)Newport Medical Instruments, Inc.2011-12-01
HAMILTON-G5 (K103803)Hamilton Medical AG2011-11-23
FLIGHT 60 VENTILATOR (K111683)Flight Medical Innovations , Ltd.2011-10-31
TRILOGY SERIES VENTILATOR WITH OXIMETRY (K111610)Respironics, Inc.2011-10-14
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE (K103625)Draeger Medical Systems, Inc.2011-10-06
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 (K111116)Datex-Ohmeda2011-09-09
V200 INTELLI-TRAK OPTION (K110795)Respironics California, Inc.2011-08-19
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 (K102120)Hsiner Co., Ltd.2011-08-12
AVEA VENTILATOR (K103211)Care Fusion2011-05-12
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR (K103318)Impact Instrumentation, Inc.2011-04-07
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION (K101850)Spacelabs Healthcare, Ltd.2011-03-02
MODEL LTV 1100 VENTILATOR (K101643)Care Fusion2011-01-26
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