MNS — Ventilator, Continuous, Non-Life-Supporting Class II
FDA product code MNS covers "Ventilator, Continuous, Non-Life-Supporting", 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
- MNS
- 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 |
|---|---|---|---|
| K251889 | Resmed | myAir | Apr 8, 2026 |
| K252078 | Compal Electronics | BreathePal Bilevel (GFM50-MD2201) | Mar 17, 2026 |
| K251661 | Resmed Pty | Mariana Minerva; Mariana Nimbus | Feb 23, 2026 |
| K240778 | Breas Medical | Vivo 1, Vivo 2 | Dec 13, 2024 |
| K231064 | Smd Manufacturing | ReddyPort Elbow | Jul 13, 2023 |
| K213169 | Bmc Medical Co | BPAP System | Dec 5, 2022 |
| K171827 | Smd Manufacturing | ReddyPort NIV Access Elbow | Jan 19, 2018 |
| K161492 | Resmed | Juno VPAP ST-A | Jan 19, 2017 |
| K161487 | Resmed | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Sep 9, 2016 |
| K153061 | Resmed | Juno VPAP ST-A | Apr 13, 2016 |
| K132371 | Resmed | EASYCARE ONLINE | Nov 22, 2013 |
| K123511 | Resmed | S9 VPAP TX | Mar 21, 2013 |
| K123557 | Resmed | EASYCARE ONLINE | Mar 14, 2013 |
| K122324 | Resmed | VPAP S-A | Nov 13, 2012 |
| K113714 | Resmed | VPAP TX | May 25, 2012 |
| K113288 | Resmed | VPAP ST-A | Mar 29, 2012 |
| K113815 | Resmed | RESSCAN | Mar 27, 2012 |
| K113053 | Respironics | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | Feb 1, 2012 |
| K112914 | Resmed | VPAP TX | Dec 29, 2011 |
| K111378 | Philips Respironics | OXIMETRY INTERFACE KIT | Oct 4, 2011 |