# Masimo Corporation (manufacturer, Irvine, CA): 20 new FDA device listings, incl. full-montage standard electroencephalograph

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Masimo Corporation |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Irvine, CA, US |
| New listings | 20 |
| Devices | Full-Montage Standard Electroencephalograph; Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide; Index-Generating Electroencephalograph Software; Oximeter, Ear; Non-Normalizing Quantitative Electroencephalograph Software; Oximeter; Monitor, Breathing Frequency; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; System, Measurement, Blood-Pressure, Non-Invasive; Monitor, Bed Patient |
| Product codes | GWQ, JKS, OLW, DPZ, OLT, DQA, BZQ, CCK, DXN, KMI, MWI, DXG, OMC, ORT, GXY |
| Device classes | Class I, Class II |
| Medical specialties | Neurology, Clinical Toxicology, Cardiovascular, Anesthesiology, General Hospital |
| Brand names | LiDCO; Root; Masimo W1 |
| First new listing | 2026-09-23 |
| Latest new listing | 2026-10-22 |
| FDA registration number | 3011353843 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.