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) → MNS — Ventilator, Continuous, Non-Life-Supporting # MNS · Ventilator, Continuous, Non-Life-Supporting _Anesthesiology · 21 CFR 868.5895 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS ## Overview - **Product Code:** MNS - **Device Name:** Ventilator, Continuous, Non-Life-Supporting - **Regulation:** [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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 47) Showing 20 most recent of 47 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251889](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K251889.md) | myAir | Resmed Corp | Apr 8, 2026 | SESE | | [K252078](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K252078.md) | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | Mar 17, 2026 | SESE | | [K251661](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K251661.md) | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | Feb 23, 2026 | SESE | | [K240778](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K240778.md) | Vivo 1, Vivo 2 | Breas Medical AB | Dec 13, 2024 | SESE | | [K231064](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K231064.md) | ReddyPort Elbow | Smd Manufacturing, LLC | Jul 13, 2023 | SESE | | [K213169](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K213169.md) | BPAP System | BMC Medical Co., Ltd. | Dec 5, 2022 | SESE | | [K171827](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K171827.md) | ReddyPort NIV Access Elbow | Smd Manufacturing, LLC | Jan 19, 2018 | SESE | | [K161492](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K161492.md) | Juno VPAP ST-A | Resmed, Ltd. | Jan 19, 2017 | SESE | | [K161487](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K161487.md) | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Resmed, Ltd. | Sep 9, 2016 | SESE | | [K153061](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K153061.md) | Juno VPAP ST-A | Resmed, Ltd. | Apr 13, 2016 | SESE | | [K132371](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K132371.md) | EASYCARE ONLINE | Resmed, Ltd. | Nov 22, 2013 | SESE | | [K123511](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K123511.md) | S9 VPAP TX | Resmed, Ltd. | Mar 21, 2013 | SESE | | [K123557](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K123557.md) | EASYCARE ONLINE | Resmed, Ltd. | Mar 14, 2013 | SESE | | [K122324](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K122324.md) | VPAP S-A | Resmed, Ltd. | Nov 13, 2012 | SESE | | [K113714](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K113714.md) | VPAP TX | Resmed, Ltd. | May 25, 2012 | SESE | | [K113288](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K113288.md) | VPAP ST-A | Resmed, Ltd. | Mar 29, 2012 | SESE | | [K113815](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K113815.md) | RESSCAN | Resmed, Ltd. | Mar 27, 2012 | SESE | | [K113053](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K113053.md) | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | Feb 1, 2012 | SESE | | [K112914](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K112914.md) | VPAP TX | Resmed, Ltd. | Dec 29, 2011 | SESE | | [K111378](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K111378.md) | OXIMETRY INTERFACE KIT | Philips Respironics, Inc. | Oct 4, 2011 | SESE | ## Top Applicants - Resmed, Ltd. — 16 clearances - Respironics, Inc. — 12 clearances - Respironics Inc., Sleep & Home Respiratory Group — 4 clearances - Breas Medical AB — 2 clearances - Resmed Corp — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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