Cleared Traditional

Mariana Minerva; Mariana Nimbus

K251661 · Resmed Pty , Ltd. · Anesthesiology
Feb 2026
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K251661 is an FDA 510(k) clearance for the Mariana Minerva; Mariana Nimbus, a Ventilator, Continuous, Non-life-supporting (Class II — Special Controls, product code MNS), submitted by Resmed Pty , Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on February 23, 2026, 269 days after receiving the submission on May 30, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K251661 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date February 23, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNS — Ventilator, Continuous, Non-life-supporting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895