CBK
- Product code
- CBK
- Device name
- Ventilator, Continuous, Facility Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5895
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 16
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 505 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (16)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253647 | 2026-05-07 | Draegerwerk AG & CO Kgaa | Evita (V800); Evita (V600) | |
| K252663 | 2026-04-14 | Iconic Solutions by Murcia, SL | Inbentus Versatile | |
| K251888 | 2026-03-12 | Hsiner Co., Ltd. | VPAP Pediatric Face Mask | |
| K232365 | 2025-12-19 | Oconnell Regulatory Consultants, Inc. | Vivo 45 LS | |
| K252173 | 2025-09-10 | Fisher & Paykel Healthcare, Ltd. | F&P OptiNIV Hospital Vented Full Face Mask Compatibl… | |
| K243767 | 2025-08-28 | Shenzhen Mindray Bio-Medical Electroni… | SV600, SV800 Ventilator | |
| K251133 | 2025-05-08 | Telesair, Inc. | AVEA disposable expiratory filter/water trap (11790) | |
| K243394 | 2024-12-30 | Respironics, Inc. | AF531 Oro-Nasal SE Face Mask | |
| K233486 | 2024-12-13 | ZOLL Medical Corporation | 731 Series Ventilator | |
| K223120 | 2024-12-02 | Flight Medical Innovations , Ltd. | Ventoux VC2; Ventoux VC3 | |
| K241135 | 2024-11-13 | Corvent Medical, Inc. | RESPOND(R) Ventilator | |
| K241943 | 2024-08-28 | Sleepnet Corporation | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face… | FDA |
| K232836 | 2024-08-14 | Dimar S.P.A. | Family of DIMAR DMAX NIV masks | |
| K240807 | 2024-08-13 | Ventis Medical, Inc. | VM-2000 | |
| K241520 | 2024-06-27 | Sleepnet Corporation | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face A… | |
| K231778 | 2024-03-01 | Nihon Kohden Orangemed, LLC | Nihon Kohden NKV-550 Series Ventilator System |
Official FDA classification page: CBK
Classification and pathway per current FDA publications. Data from openFDA (CC0).