S10 Kirra— 510(k) K203126

Name: FDA 510(k) clearance K203126
Creator: U.S. Food and Drug Administration
Published: 2020-12-18

Substantially Equivalent

Resmed Pty , Ltd.

FDA 510(k) clearance K203126 for S10 Kirra, Substantially Equivalent on 2020-12-18. Applicant: Resmed Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Resmed Pty , Ltd.
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2020-10-19
Decision date: 2020-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bella Vista, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.