Mariana Minerva; Mariana Nimbus— 510(k) K251661
Substantially EquivalentResmed Pty , Ltd.
FDA 510(k) clearance K251661 for Mariana Minerva; Mariana Nimbus, Substantially Equivalent on 2026-02-23. Applicant: Resmed Pty , Ltd.. Device class: 2.
Summary
Resmed Pty Ltd's record names two devices, Mariana Minerva and Mariana Nimbus, under product code MNS (Ventilator, Continuous, Non-Life-Supporting). The record doesn't say how the two differ.
Class II, 21 CFR 868.5895. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Resmed filed from Bella Vista, Australia. The substantially equivalent decision came 269 calendar days after receipt (May 30, 2025 to February 23, 2026).
Clearance details
- Applicant
- Resmed Pty , Ltd.
- Product code
- Product code MNS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bella Vista, AU
Recent devices under product code MNS
view allMore clearances from Resmed Pty , Ltd.
view allAdverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.