MNS — Ventilator, Continuous, Non-Life-Supporting Class II
FDA Device Classification
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 |
|---|
| 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 |
| K102465 | respironics | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | March 24, 2011 |
| K101130 | respironics | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK | September 2, 2010 |