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 | April 8, 2026 |
| K252078 | compal electronics | BreathePal Bilevel (GFM50-MD2201) | March 17, 2026 |
| K251661 | resmed pty | Mariana Minerva; Mariana Nimbus | February 23, 2026 |
| K240778 | breas medical | Vivo 1, Vivo 2 | December 13, 2024 |
| K231064 | smd manufacturing | ReddyPort Elbow | July 13, 2023 |
| K213169 | bmc medical co | BPAP System | December 5, 2022 |
| K171827 | smd manufacturing | ReddyPort NIV Access Elbow | January 19, 2018 |
| K161492 | resmed | Juno VPAP ST-A | January 19, 2017 |
| K161487 | resmed | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | September 9, 2016 |
| K153061 | resmed | Juno VPAP ST-A | April 13, 2016 |
| K132371 | resmed | EASYCARE ONLINE | November 22, 2013 |
| K123511 | resmed | S9 VPAP TX | March 21, 2013 |
| K123557 | resmed | EASYCARE ONLINE | March 14, 2013 |
| K122324 | resmed | VPAP S-A | November 13, 2012 |
| K113714 | resmed | VPAP TX | May 25, 2012 |
| K113288 | resmed | VPAP ST-A | March 29, 2012 |
| K113815 | resmed | RESSCAN | March 27, 2012 |
| K113053 | respironics | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | February 1, 2012 |
| K112914 | resmed | VPAP TX | December 29, 2011 |
| K111378 | philips respironics | OXIMETRY INTERFACE KIT | October 4, 2011 |