Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895) → CBK — Ventilator, Continuous, Facility Use # CBK · Ventilator, Continuous, Facility Use _Anesthesiology · 21 CFR 868.5895 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK ## Overview - **Product Code:** CBK - **Device Name:** Ventilator, Continuous, Facility Use - **Regulation:** [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K252663.md) | Inbentus Versatile | Iconic Solutions by Murcia, SL | Apr 14, 2026 | SESE | | [K251888](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K251888.md) | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | Mar 12, 2026 | SESE | | [K232365](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K232365.md) | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | Dec 19, 2025 | SESE | | [K252173](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K252173.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K243767.md) | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Aug 28, 2025 | SESE | | [K251133](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K251133.md) | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | May 8, 2025 | SESE | | [K243394](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K243394.md) | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | Dec 30, 2024 | SESE | | [K233486](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K233486.md) | 731 Series Ventilator | ZOLL Medical Corporation | Dec 13, 2024 | SESE | | [K223120](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K223120.md) | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | Dec 2, 2024 | SESE | | [K241135](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K241135.md) | RESPOND(R) Ventilator | Corvent Medical, Inc. | Nov 13, 2024 | SESE | | [K241943](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K241943.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K232836.md) | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | Aug 14, 2024 | SESE | | [K240807](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K240807.md) | VM-2000 | Ventis Medical, Inc. | Aug 13, 2024 | SESE | | [K241520](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K241520.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K231778.md) | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | Mar 1, 2024 | SESE | | [K213098](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K213098.md) | Panther 5 | Origin Medical Devices | Jul 20, 2023 | SESE | | [K220107](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K220107.md) | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jun 16, 2023 | SESE | | [K222644](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K222644.md) | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | May 31, 2023 | SESE | | [K222207](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K222207.md) | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | May 16, 2023 | SESE | | [K222024](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K222024.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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