X-PLO2R— 510(k) K203086

Substantially Equivalent

Belluscura, LLC

FDA 510(k) clearance K203086 for X-PLO2R, Substantially Equivalent on 2021-03-02. Applicant: Belluscura, LLC.

Clearance details

Applicant: Belluscura, LLC
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2020-10-13
Decision date: 2021-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.