MNS · Ventilator, Continuous, Non-Life-Supporting
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | MNS |
|---|---|
| Device Name | Ventilator, Continuous, Non-Life-Supporting |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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 | myAir | Resmed Corp | Apr 8, 2026 | SESE |
| K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | Mar 17, 2026 | SESE |
| K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | Feb 23, 2026 | SESE |
| K240778 | Vivo 1, Vivo 2 | Breas Medical AB | Dec 13, 2024 | SESE |
| K231064 | ReddyPort Elbow | Smd Manufacturing, LLC | Jul 13, 2023 | SESE |
| K213169 | BPAP System | BMC Medical Co., Ltd. | Dec 5, 2022 | SESE |
| K171827 | ReddyPort NIV Access Elbow | Smd Manufacturing, LLC | Jan 19, 2018 | SESE |
| K161492 | Juno VPAP ST-A | Resmed, Ltd. | Jan 19, 2017 | SESE |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Resmed, Ltd. | Sep 9, 2016 | SESE |
| K153061 | Juno VPAP ST-A | Resmed, Ltd. | Apr 13, 2016 | SESE |
| K132371 | EASYCARE ONLINE | Resmed, Ltd. | Nov 22, 2013 | SESE |
| K123511 | S9 VPAP TX | Resmed, Ltd. | Mar 21, 2013 | SESE |
| K123557 | EASYCARE ONLINE | Resmed, Ltd. | Mar 14, 2013 | SESE |
| K122324 | VPAP S-A | Resmed, Ltd. | Nov 13, 2012 | SESE |
| K113714 | VPAP TX | Resmed, Ltd. | May 25, 2012 | SESE |
| K113288 | VPAP ST-A | Resmed, Ltd. | Mar 29, 2012 | SESE |
| K113815 | RESSCAN | Resmed, Ltd. | Mar 27, 2012 | SESE |
| K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | Feb 1, 2012 | SESE |
| K112914 | VPAP TX | Resmed, Ltd. | Dec 29, 2011 | SESE |
| K111378 | 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
- Smd Manufacturing, LLC — 2 clearances
- Resmed Corp — 2 clearances
