Cleared Traditional

S10 Kirra

K203126 · Resmed Pty , Ltd. · Anesthesiology

Dec 2020

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K203126 is an FDA 510(k) clearance for the S10 Kirra, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed Pty , Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on December 18, 2020, 60 days after receiving the submission on October 19, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K203126 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 2020
Decision Date	December 18, 2020
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF