Masimo Root Monitoring System— 510(k) K253417
Substantially EquivalentMasimo Corporation
FDA 510(k) clearance K253417 for Masimo Root Monitoring System, Substantially Equivalent on 2026-08-12. Applicant: Masimo Corporation. Device class: 2.
Summary
Masimo's Masimo Root Monitoring System is filed under product code MWI, physiological patient monitors without arrhythmia detection or alarms. The record gives no model numbers.
Class II, 21 CFR 870.2300. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Masimo filed from Irvine, California. Review took 315 calendar days (October 1, 2025 to August 12, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Masimo Corporation
- Product code
- Product code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code MWI
view allMore clearances from Masimo Corporation
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . 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.