Panels › Anesthesiology › Product code CBK · Class 2
Ventilator, Continuous, Facility Use
Regulation 868.5895
4510(k)s in 12 months (505 all time)
23recalls in 12 months (336 all time)
306recalls that name a 510(k)
Top companies in CBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Medical AG | 35 | 31 |
| Philips Respironics | 0 | 54 |
| Draeger Medical AG & Co. KG | 14 | 26 |
| Puritan Bennett Corp. | 34 | 1 |
| Newport Medical Instruments, Inc. | 17 | 12 |
| Respironics, Inc. | 14 | 14 |
| Covidien | 4 | 23 |
| Bird Products Corp. | 21 | 0 |
| Respironics California, Inc. | 8 | 13 |
| Bio-Med Devices, Inc. | 9 | 8 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 7, 2026 | K253647 | Evita (V800); Evita (V600) Draegerwerk AG & CO Kgaa, DE | CBK |
| Apr 14, 2026 | K252663 | Inbentus Versatile Iconic Solutions by Murcia, SL, ES | CBK |
| Mar 12, 2026 | K251888 | VPAP Pediatric Face Mask Hsiner Co., Ltd., TW | CBK |
| Dec 19, 2025 | K232365 | Vivo 45 LS Oconnell Regulatory Consultants, Inc. | CBK |
| Sep 10, 2025 | K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospita Fisher & Paykel Healthcare, Ltd., NZ | CBK |
| Aug 28, 2025 | K243767 | SV600, SV800 Ventilator Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | CBK |
| May 8, 2025 | K251133 | AVEA disposable expiratory filter/water trap (11790) Telesair, Inc. | CBK |
| Dec 30, 2024 | K243394 | AF531 Oro-Nasal SE Face Mask Respironics, Inc. | CBK |
| Dec 13, 2024 | K233486 | 731 Series Ventilator ZOLL Medical Corporation | CBK |
| Dec 2, 2024 | K223120 | Ventoux VC2; Ventoux VC3 Flight Medical Innovations , Ltd., IL | CBK |
| Nov 13, 2024 | K241135 | RESPOND(R) Ventilator Corvent Medical, Inc. | CBK |
| Aug 28, 2024 | K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask Sleepnet Corporation | CBK |
| Aug 14, 2024 | K232836 | Family of DIMAR DMAX NIV masks Dimar S.P.A., IT | CBK |
| Aug 13, 2024 | K240807 | VM-2000 Ventis Medical, Inc. | CBK |
| Jun 27, 2024 | 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 Sleepnet Corporation | CBK |
| Mar 1, 2024 | K231778 | Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden Orangemed, LLC | CBK |
| Jul 20, 2023 | K213098 | Panther 5 Origin Medical Devices | CBK |
| Jun 16, 2023 | K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | CBK |
| May 31, 2023 | K222644 | Nihon Kohden NKV-440 Ventilator System Nihon Kohden Orangemed, Inc. | CBK |
| May 16, 2023 | K222207 | Babylog VN800, Babylog VN600 Draegerwerk AG & CO Kgaa, DE | CBK |
| May 16, 2023 | K222024 | Evita V800, Evita V600 Draegerwerk AG & CO Kgaa, DE | CBK |
| Nov 10, 2021 | K201082 | LTV2 Series Ventilators Vyaire Medical, Inc. | CBK |
| Nov 4, 2021 | K210384 | CARESCAPE R860 Datex-Ohmeda, Inc. | CBK |
| Apr 20, 2021 | K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 Maquet Critical Care AB, SE | CBK |
| Apr 14, 2021 | K203449 | F&P Visairo NIV Mask Range Fisher & Paykel Healthcare, Ltd., NZ | CBK |
| Feb 5, 2021 | K201306 | HAMILTON-C3 Hamilton Medical AG, CH | CBK |
| Jan 29, 2021 | K202970 | Ventway Sparrow Inovytech Medical Solutions , Ltd., IL | CBK |
| Dec 11, 2020 | K201658 | Hamilton-C6 Hamilton Medical AG, CH | CBK |
| Nov 20, 2020 | K193056 | Puritan Bennett 980 Series Ventilator System Covidien, LLC | CBK |
| Jun 18, 2020 | K192604 | Servo-air 4.0 Ventilator System Maquet Critica Care AB, SE | CBK |
| May 4, 2020 | K193228 | Hamilton-G5 Hamilton Medical AG, CH | CBK |
| Jan 10, 2020 | K192307 | Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden Orangemed, Inc. | CBK |
| Sep 13, 2019 | K183364 | Bellavista Imtmedical AG, CH | CBK |
| Aug 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 Hamilton Medical AG, CH | CBK |
| Jul 30, 2019 | K180295 | Hamilton-G5 Hamiton Medical AG, CH | CBK |
| Jul 26, 2019 | 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 Sleepnet Corporation | CBK |
| Jul 18, 2019 | K181170 | Trilogy Evo Universal Respironics, Inc. | CBK |
| Jul 18, 2019 | K181166 | Trilogy Evo Respironics, Inc. | CBK |
| Mar 19, 2019 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 Maquet Critical Care AB, SE | CBK |
| Jan 17, 2019 | K180779 | Savina 300 Dragerwerk AG & CO Kgaa, DE | CBK |
| Dec 7, 2018 | K181695 | Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden Orangemed, Inc. | CBK |
| Jul 20, 2018 | K173973 | TV-100 Bio-Med Devices, Inc. | CBK |
| Apr 26, 2018 | K172875 | Astral 100/150 Resmed, Ltd., AU | CBK |
| Jan 25, 2018 | K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version Fisher and Paykel Healthcare Limited, NZ | CBK |
| Oct 27, 2017 | K162738 | Puritan Bennett 980 Ventilator System Covidien | CBK |
| Aug 11, 2017 | K170037 | Breathe Technologies Life2000 Ventilation System Breathe Technologies | CBK |
| Aug 2, 2017 | K162832 | 731 Series Ventilators ZOLL Medical Corporation | CBK |
| Jul 31, 2017 | K163127 | bellavista 1000 Imtmedical AG, CH | CBK |
| Apr 27, 2017 | K161450 | HAMILTON-C3 Hamilton Medical AG, CH | CBK |
| Apr 7, 2017 | K162877 | VOCSN Unified Respiratory System Ventec Life Systems, Inc. | CBK |
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