Murata Vios, Inc.
Woodbury, MN, US
Murata Vios, Inc. appears in FDA device records in Woodbury, MN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Murata Vios, Inc. between 2024 and 2025. The busiest year on record is 2024, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | DXN | Substantially Equivalent | |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | DRT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015328411 | 3015328411 | Murata Vios, Inc. | 700 Commerce Drive, Suite 190, Woodbury, MN 55125 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- OUGMedical Device Data System
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DPZOximeter, Ear
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1292-2025 | Vios Monitoring System Bedside Monitor Model BSM2050 | Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues. | Class II | Open, Classified | |
| Z-1069-2025 | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor. | Class II | Open, Classified | |
| Z-1169-2025 | Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00 | A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system. | Class II | Open, Classified | |
| Z-0956-2025 | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor. | Class II | Completed |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain