Masimo Root Vital Signs Monitoring System and Accessories— 510(k) K151644

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K151644 for Masimo Root Vital Signs Monitoring System and Accessories, Substantially Equivalent on 2016-02-12. Applicant: Masimo Corporation.

Clearance details

Applicant: Masimo Corporation
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2015-06-18
Decision date: 2016-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.