Mariana Minerva; Mariana Nimbus— 510(k) K251661

Substantially Equivalent

Resmed Pty , Ltd.

FDA 510(k) clearance K251661 for Mariana Minerva; Mariana Nimbus, Substantially Equivalent on 2026-02-23. Applicant: Resmed Pty , Ltd..

Clearance details

Applicant: Resmed Pty , Ltd.
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2025-05-30
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bella Vista, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.