Data / Medical devices / United States / Murata Vios, Inc.
Murata Vios, Inc.: FDA-registered device maker in Woodbury, MN, United States, 4 510(k) clearances
Murata Vios, Inc. is registered with the FDA (registration 3015328411) in Woodbury, MN, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 23, 2025. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015328411
- Address
- 700 Commerce Drive, Suite 190, Woodbury, MN, United States, 55125
- Owner or operator
- Murata Vios, Inc. (10059850)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- February 28, 2019
- Registered through
- 2027
- Brand names listed
- Vios Central Station Monitor/Vios Central Server Software 2050, Vios Monitoring System, Vios Monitoring System Model 2050
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Display, Cathode-Ray Tube, Medical | DXJ | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Oximeter, Ear | DPZ | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2025 | K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | DXN | Substantially Equivalent | Murata Vios, Inc. | accessdata.fda.gov |
| March 22, 2024 | K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | DRT | Substantially Equivalent | Murata Vios, Inc. | accessdata.fda.gov |
| July 26, 2018 | K173107 | Vios Central Station Monitor Software, Vios Central Server Software | DXJ | Substantially Equivalent | Vios Medical, Inc. | accessdata.fda.gov |
| June 22, 2018 | K172586 | Vios Monitoring System Model 2050 | DRT | Substantially Equivalent | Vios Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 9, 2024 | 96252 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 22, 2024 | 96169 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 6, 2023 | 96133 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 21, 2021 | 96078 | Class II | Completed | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Oximeter, Ear
- All makers of Oximeter
- All makers of Medical Device Data System
- All makers of Display, Cathode-Ray Tube, Medical
Updated March 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.