CBK · Ventilator, Continuous, Facility Use
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | CBK |
|---|---|
| Device Name | Ventilator, Continuous, Facility Use |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 504)
Showing 20 most recent of 504 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | Apr 14, 2026 | SESE |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | Mar 12, 2026 | SESE |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | Dec 19, 2025 | SESE |
| 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. | Sep 10, 2025 | SESE |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Aug 28, 2025 | SESE |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | May 8, 2025 | SESE |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | Dec 30, 2024 | SESE |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | Dec 13, 2024 | SESE |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | Dec 2, 2024 | SESE |
| K241135 | RESPOND(R) Ventilator | Corvent Medical, Inc. | Nov 13, 2024 | SESE |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Sleepnet Corporation | Aug 28, 2024 | SESE |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | Aug 14, 2024 | SESE |
| K240807 | VM-2000 | Ventis Medical, Inc. | Aug 13, 2024 | SESE |
| 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 | Jun 27, 2024 | SESE |
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | Mar 1, 2024 | SESE |
| K213098 | Panther 5 | Origin Medical Devices | Jul 20, 2023 | SESE |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jun 16, 2023 | SESE |
| K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | May 31, 2023 | SESE |
| K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | May 16, 2023 | SESE |
| K222024 | Evita V800, Evita V600 | Draegerwerk AG & CO Kgaa | May 16, 2023 | SESE |
Top Applicants
- Puritan Bennett Corp. — 33 clearances
- Hamilton Medical AG — 25 clearances
- Bird Products Corp. — 21 clearances
- Newport Medical Instruments, Inc. — 17 clearances
- Siemens Elema AB — 15 clearances
