CBK — Ventilator, Continuous, Facility Use Class II
FDA product code CBK covers "Ventilator, Continuous, Facility Use", a Class II medical device regulated under 21 CFR 868.5895. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CBK
- Device Class
- Class II
- Regulation Number
- 868.5895
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253647 | draegerwerk ag and co kgaa | Evita (V800); Evita (V600) | May 7, 2026 |
| K252663 | iconic solutions by murcia, sl | Inbentus Versatile | April 14, 2026 |
| K251888 | hsiner co | VPAP Pediatric Face Mask | March 12, 2026 |
| K232365 | oconnell regulatory consultants | Vivo 45 LS | December 19, 2025 |
| K252173 | fisher and paykel healthcare | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits | September 10, 2025 |
| K243767 | shenzhen mindray bio-medical electronics co | SV600, SV800 Ventilator | August 28, 2025 |
| K251133 | telesair | AVEA disposable expiratory filter/water trap (11790) | May 8, 2025 |
| K243394 | respironics | AF531 Oro-Nasal SE Face Mask | December 30, 2024 |
| K233486 | zoll medical corporation | 731 Series Ventilator | December 13, 2024 |
| K223120 | flight medical innovations | Ventoux VC2; Ventoux VC3 | December 2, 2024 |
| K241135 | corvent medical | RESPOND(R) Ventilator | November 13, 2024 |
| K241943 | sleepnet corporation | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 | August 28, 2024 |
| K232836 | dimar | Family of DIMAR DMAX NIV masks | August 14, 2024 |
| K240807 | ventis medical | VM-2000 | August 13, 2024 |
| K241520 | sleepnet corporation | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal | June 27, 2024 |
| K231778 | nihon kohden orangemed | Nihon Kohden NKV-550 Series Ventilator System | March 1, 2024 |
| K213098 | origin medical devices | Panther 5 | July 20, 2023 |
| K220107 | shenzhen mindray bio-medical electronics co | Mindray SV600 Ventilator, Mindray SV800 Ventilator | June 16, 2023 |
| K222644 | nihon kohden orangemed | Nihon Kohden NKV-440 Ventilator System | May 31, 2023 |
| K222024 | draegerwerk ag and co kgaa | Evita V800, Evita V600 | May 16, 2023 |