FDA Product Code
FDA Product Code CBK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5895
510(k) Clearances — 505 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026-05-07 | Traditional | PDF ↗ |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026-04-14 | Traditional | PDF ↗ |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026-03-12 | Traditional | PDF ↗ |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| 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. | 2025-09-10 | Traditional | PDF ↗ |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 | Traditional | PDF ↗ |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | 2025-05-08 | Traditional | PDF ↗ |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024-12-30 | Traditional | PDF ↗ |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024-12-13 | Traditional | PDF ↗ |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | 2024-12-02 | Traditional | PDF ↗ |
| K241135 | RESPOND(R) Ventilator | Corvent Medical, Inc. | 2024-11-13 | Traditional | PDF ↗ |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Sleepnet Corporation | 2024-08-28 | Traditional | PDF ↗ |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | 2024-08-14 | Traditional | PDF ↗ |
| K240807 | VM-2000 | Ventis Medical, Inc. | 2024-08-13 | Traditional | PDF ↗ |
| 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 | 2024-06-27 | Special | PDF ↗ |
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | 2024-03-01 | Traditional | PDF ↗ |
| K213098 | Panther 5 | Origin Medical Devices | 2023-07-20 | Traditional | PDF ↗ |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-16 | Traditional | PDF ↗ |
| K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | 2023-05-31 | Traditional | PDF ↗ |
| K222024 | Evita V800, Evita V600 | Draegerwerk AG & CO Kgaa | 2023-05-16 | Traditional | PDF ↗ |
| K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | 2023-05-16 | Traditional | PDF ↗ |
| K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021-11-10 | Traditional | PDF ↗ |
| K210384 | CARESCAPE R860 | Datex-Ohmeda, Inc. | 2021-11-04 | Traditional | PDF ↗ |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | Maquet Critical Care AB | 2021-04-20 | Traditional | PDF ↗ |
| K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | 2021-04-14 | Traditional | PDF ↗ |
| K201306 | HAMILTON-C3 | Hamilton Medical AG | 2021-02-05 | Traditional | PDF ↗ |
| K202970 | Ventway Sparrow | Inovytech Medical Solutions , Ltd. | 2021-01-29 | Traditional | PDF ↗ |
| K201658 | Hamilton-C6 | Hamilton Medical AG | 2020-12-11 | Traditional | PDF ↗ |
| K193056 | Puritan Bennett 980 Series Ventilator System | Covidien, LLC | 2020-11-20 | Traditional | PDF ↗ |
| K192604 | Servo-air 4.0 Ventilator System | Maquet Critica Care AB | 2020-06-18 | Traditional | PDF ↗ |
| K193228 | Hamilton-G5 | Hamilton Medical AG | 2020-05-04 | Traditional | PDF ↗ |
| K192307 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2020-01-10 | Traditional | PDF ↗ |
| K183364 | Bellavista | Imtmedical AG | 2019-09-13 | Traditional | PDF ↗ |
| K181216 | HAMILTON-T1, HAMILTON-C1 | Hamilton Medical AG | 2019-08-02 | Traditional | PDF ↗ |
| K180295 | Hamilton-G5 | Hamiton Medical AG | 2019-07-30 | Traditional | PDF ↗ |
| 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 | 2019-07-26 | Traditional | PDF ↗ |
| K181166 | Trilogy Evo | Respironics, Inc. | 2019-07-18 | Traditional | PDF ↗ |
| K181170 | Trilogy Evo Universal | Respironics, Inc. | 2019-07-18 | Traditional | PDF ↗ |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Maquet Critical Care AB | 2019-03-19 | Traditional | PDF ↗ |
| K180779 | Savina 300 | Dragerwerk AG & CO Kgaa | 2019-01-17 | Traditional | PDF ↗ |
| K181695 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2018-12-07 | Traditional | PDF ↗ |
| K173973 | TV-100 | Bio-Med Devices, Inc. | 2018-07-20 | Traditional | PDF ↗ |
| K172875 | Astral 100/150 | Resmed, Ltd. | 2018-04-26 | Traditional | PDF ↗ |
| K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | Fisher and Paykel Healthcare Limited | 2018-01-25 | Traditional | PDF ↗ |
| K162738 | Puritan Bennett 980 Ventilator System | Covidien | 2017-10-27 | Traditional | PDF ↗ |
| K170037 | Breathe Technologies Life2000 Ventilation System | Breathe Technologies | 2017-08-11 | Traditional | PDF ↗ |
| K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017-08-02 | Traditional | PDF ↗ |
| K163127 | bellavista 1000 | Imtmedical AG | 2017-07-31 | Traditional | PDF ↗ |
| K161450 | HAMILTON-C3 | Hamilton Medical AG | 2017-04-27 | Traditional | PDF ↗ |
| K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017-04-07 | Traditional | PDF ↗ |
| K153046 | HAMILTON-MR1 | Hamilton Medical AG | 2016-09-06 | Traditional | PDF ↗ |
| K152068 | Astral 100/150 | Resmed, Ltd. | 2016-05-13 | Traditional | PDF ↗ |
| K143035 | Flight 60 Ventilator | Flight Medical Innovations , Ltd. | 2016-03-30 | Traditional | PDF ↗ |
| K151252 | Puritan Bennett 840 Series Ventilator System | Covidien LP | 2016-03-29 | Traditional | PDF ↗ |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Maquet Critical Care AB | 2015-12-21 | Traditional | PDF ↗ |
| K151901 | AirView | Resmed, Ltd. | 2015-11-05 | Traditional | PDF ↗ |
| K150638 | AF541 SE Full Face Mask | Respironics, Inc. | 2015-09-18 | Abbreviated | PDF ↗ |
| K140939 | HAMILTON-T1,HAMILTON-C1 | Hamilton Medical AG | 2015-09-02 | Traditional | PDF ↗ |
| K142679 | CARESCAPE R860 | Datex-Ohmeda, Inc. | 2015-06-12 | Traditional | PDF ↗ |
| K141943 | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM | Breathe Technologies | 2015-06-12 | Traditional | PDF ↗ |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Datex-Ohmeda, Inc. | 2015-02-03 | Traditional | PDF ↗ |
| K121886 | SAVINA 300 SAVINA 300, COUNTRY VARIANTS | Draeger Medical GmbH | 2014-08-08 | Traditional | PDF ↗ |
| K123149 | SERVO-I VENTILATOR SYSTEM | Maquet Critical Care AB | 2014-06-20 | Abbreviated | PDF ↗ |
| K133868 | ASTRAL VENTILATOR | Resmed, Ltd. | 2014-06-04 | Traditional | PDF ↗ |
| K130171 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | 2014-04-08 | Traditional | PDF ↗ |
| K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM | Covidien | 2014-02-24 | Traditional | PDF ↗ |
| K122438 | HAMILTON-MR1 | Hamilton Medical AG | 2013-11-20 | Abbreviated | PDF ↗ |
| K130178 | INSPIRATION VENTILATOR SYSTEM 5I/7I | eVent Medical, Ltd. | 2013-10-29 | Traditional | PDF ↗ |
| K131774 | HAMILTON-G5 | Hamilton Medical AG | 2013-10-09 | Traditional | PDF ↗ |
| K120931 | CRITICAL CARE VENTILATOR | Oricare, Inc. | 2013-06-06 | Traditional | PDF ↗ |
| K122560 | VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 | Pan-America Hyperbarics, Inc. | 2013-03-26 | Traditional | PDF ↗ |
| K123637 | HAMILTON-C3 | Hamilton Medical AG | 2012-12-21 | Special | PDF ↗ |
| K113743 | EVOLUTION 3E VENTILATOR | Event Medical, Inc. | 2012-12-18 | Traditional | PDF ↗ |
| K120146 | QUARK SERIES | Cosmed Srl | 2012-12-11 | Traditional | PDF ↗ |
| K121225 | HAMILTON-C2 | Hamilton Medical AG | 2012-11-16 | Traditional | PDF ↗ |
| K121891 | NEWPORT AURA VENTILATOR | Newport Medical Instruments, Inc. | 2012-11-09 | Traditional | PDF ↗ |
| K121379 | PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY | Airon Corporation | 2012-10-11 | Traditional | PDF ↗ |
| K120639 | PERFORMAX PEDIATRIC SE TOTAL FACE MASK | Respironics, Inc. | 2012-07-10 | Traditional | PDF ↗ |
| K120726 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | 2012-07-06 | Traditional | PDF ↗ |
| K112754 | IVENT101 | Versamed Medical Systems , Ltd. | 2012-06-15 | Traditional | PDF ↗ |
| K112729 | BLEASE700/900 SERIES VENTILATORS | Spacelabs Healthcare | 2012-06-11 | Traditional | PDF ↗ |
| K120574 | HAMILTON-C1 | Hamilton Medical AG | 2012-05-30 | Abbreviated | PDF ↗ |
| K120670 | HAMILTON-T1 | Hamilton Medical AG | 2012-04-03 | Special | PDF ↗ |
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION | Spacelabs Healthcare | 2012-03-22 | Traditional | PDF ↗ |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR | Impact Instrumentation, Inc. | 2012-02-16 | Traditional | PDF ↗ |
| K112006 | HAMILTON-TC1 | Hamilton Medical AG | 2012-02-09 | Traditional | PDF ↗ |
| K111595 | NEUMOVENT GRAPHNET | Tecme S.A. | 2012-01-27 | Traditional | PDF ↗ |
| K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE | Respironics California, Inc. | 2012-01-13 | Traditional | PDF ↗ |
| K111146 | NEWPORT HT70 VENTILATOR | Newport Medical Instruments, Inc. | 2011-12-01 | Traditional | PDF ↗ |
| K103803 | HAMILTON-G5 | Hamilton Medical AG | 2011-11-23 | Traditional | PDF ↗ |
| K111683 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | 2011-10-31 | Traditional | PDF ↗ |
| K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY | Respironics, Inc. | 2011-10-14 | Abbreviated | PDF ↗ |
| K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE | Draeger Medical Systems, Inc. | 2011-10-06 | Traditional | PDF ↗ |
| K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 | Datex-Ohmeda | 2011-09-09 | Traditional | PDF ↗ |
| K110795 | V200 INTELLI-TRAK OPTION | Respironics California, Inc. | 2011-08-19 | Traditional | PDF ↗ |
| K102120 | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 | Hsiner Co., Ltd. | 2011-08-12 | Traditional | PDF ↗ |
| K103211 | AVEA VENTILATOR | Care Fusion | 2011-05-12 | Traditional | PDF ↗ |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR | Impact Instrumentation, Inc. | 2011-04-07 | Traditional | PDF ↗ |
| K101850 | SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION | Spacelabs Healthcare, Ltd. | 2011-03-02 | Traditional | PDF ↗ |
| K101643 | MODEL LTV 1100 VENTILATOR | Care Fusion | 2011-01-26 | Traditional | PDF ↗ |
Product code CBK · Class II · Anesthesiology. Data: openFDA.