FDA 510(k) · Masimo
K253417: Masimo Root Monitoring System (Masimo Corporation)
Masimo Corporation received FDA 510(k) K253417 for Masimo Root Monitoring System, with a decision date of Aug 12, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K253417 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo Root Monitoring System |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Oct 1, 2025 |
| Decision date | Aug 12, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Masimo Root Monitoring System is The Masimo Root Monitoring System is The LiDCOrapid Different. The subject indicated for use by healthcare professionals indicated for use by healthcare professionals Hemodynamic Monitoring device has expanded for the monitoring of multiple physiological for the monitoring of multiple physiological System is intended for use indications for parameters in healthcare environments. The parameters in healthcare environments. The under the direct supervision hemodynamic Root Monitoring System, when used with Root Monitoring System, when used with the of a licensed healthcare monitoring, the same as the optional ISA module, is not intended to optional ISA module, is not intended to be practitioner or by personnel the secondary predicate. be used in road ambulances. used in road ambulances. trained in its proper use for 510(k) Summary (K253417) Feature Masimo Root with LiDCO Module, Masimo Root, Primary
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MWI is "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.2300.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.