Radius T wearable thermometer— 510(k) K203215

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K203215 for Radius T wearable thermometer, Substantially Equivalent on 2021-06-11. Applicant: Masimo Corporation.

Clearance details

Applicant: Masimo Corporation
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-11-02
Decision date: 2021-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.