Product code CBK
- Device name
- Ventilator, Continuous, Facility Use
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5895
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026-05-07 |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026-04-14 |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026-03-12 |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025-12-19 |
| 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 Fa... | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | 2025-05-08 |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024-12-30 |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024-12-13 |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | 2024-12-02 |
| K241135 | RESPOND(R) Ventilator | Corvent Medical, Inc. | 2024-11-13 |
| 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 |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | 2024-08-14 |
| K240807 | VM-2000 | Ventis Medical, Inc. | 2024-08-13 |
| 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 |
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | 2024-03-01 |
| K213098 | Panther 5 | Origin Medical Devices | 2023-07-20 |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-16 |
| K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | 2023-05-31 |
| K222024 | Evita V800, Evita V600 | Draegerwerk AG & CO Kgaa | 2023-05-16 |
| K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | 2023-05-16 |
| K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021-11-10 |
| K210384 | CARESCAPE R860 | Datex-Ohmeda, Inc. | 2021-11-04 |
| 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 |
| K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | 2021-04-14 |
| K201306 | HAMILTON-C3 | Hamilton Medical AG | 2021-02-05 |
| K202970 | Ventway Sparrow | Inovytech Medical Solutions , Ltd. | 2021-01-29 |
| K201658 | Hamilton-C6 | Hamilton Medical AG | 2020-12-11 |
| K193056 | Puritan Bennett 980 Series Ventilator System | Covidien, LLC | 2020-11-20 |
| K192604 | Servo-air 4.0 Ventilator System | Maquet Critica Care AB | 2020-06-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00198843002920 | bellavista | Zoll Medical Corporation | 2026-07-22 |
| 00198843002913 | bellavista | Zoll Medical Corporation | 2026-07-22 |
| 00198843002869 | bellavista | Zoll Medical Corporation | 2026-07-10 |
| 00198843002852 | bellavista | Zoll Medical Corporation | 2026-07-10 |
| 00198843002876 | bellavista | Zoll Medical Corporation | 2026-07-06 |
| 00198843001152 | bellavista | Zoll Medical Corporation | 2026-06-24 |
| 00198843001145 | bellavista | Zoll Medical Corporation | 2026-06-24 |
| 09420012477484 | F&P OptiNIV | FISHER & PAYKEL HEALTHCARE LIMITED | 2025-12-06 |
| 09420012477477 | F&P OptiNIV | FISHER & PAYKEL HEALTHCARE LIMITED | 2025-12-06 |
| 04048675449119 | VentStar Oxylog 3000F,2000p 5x | Drägerwerk AG & Co. KGaA | 2024-12-05 |
| 04048675542148 | Evita V800 | Drägerwerk AG & Co. KGaA | 2023-06-02 |
| 04048675551713 | Babylog VN600 | Drägerwerk AG & Co. KGaA | 2023-06-02 |
| 04048675548744 | Evita V600 | Drägerwerk AG & Co. KGaA | 2023-06-02 |
| 04048675542476 | Babylog VN800 | Drägerwerk AG & Co. KGaA | 2023-06-02 |
| 04048675000983 | Neonatal flow sensor, Y-piece | Drägerwerk AG & Co. KGaA | 2023-04-04 |
| 04048675425670 | VentStar Oxylog3000F,2000p 150 | Drägerwerk AG & Co. KGaA | 2022-06-17 |
| 04048675425656 | VentStar Oxylog 3000F (P) 190 | Drägerwerk AG & Co. KGaA | 2022-06-17 |
| 04048675422174 | VentStar Oxylog3000F,2000p 300 | Drägerwerk AG & Co. KGaA | 2022-06-17 |
| 04048675421627 | Exp-Valve disp RFID | Drägerwerk AG & Co. KGaA | 2022-06-17 |
| 04048675421610 | Exp-Valve disposable | Drägerwerk AG & Co. KGaA | 2022-06-17 |
| 04048675252313 | Ventstar Oxylog 1000 180 | Drägerwerk AG & Co. KGaA | 2022-06-17 |
| 04048675448853 | Neonatal flow sensor insert | Drägerwerk AG & Co. KGaA | 2022-04-08 |
| 04048675000099 | Neonatal flow sensor ISO15 | Drägerwerk AG & Co. KGaA | 2022-04-08 |
| 10841522100406 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522100413 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 00849436000204 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2015-10-30 |
| 00849436000426 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2015-10-30 |
| 04048675251422 | Savina 300 | Drägerwerk AG & Co. KGaA | 2015-10-24 |
| 04048675042266 | IACS Workstation Critical Care | Drägerwerk AG & Co. KGaA | 2015-10-24 |
| 04048675016403 | Savina System | Drägerwerk AG & Co. KGaA | 2015-10-24 |