📊 Evidence-Based Reference
Dose 1 0
Mvision Ai Oy
Summary: Dose 1 0 is a dialysis-access device by Mvision Ai Oy, cleared by the FDA via 510k. It is primarily used in dialysis procedures, with evidence supporting its safety and efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K250064 ↗
Decision Date ?
September 4, 2025
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
Dose 1 0 was cleared by the FDA through the 510k pathway on September 4, 2025. It is manufactured by Mvision Ai Oy and classified as a Class 2 device.
What It Is
Dose 1 0 is a medical device designed for use in dialysis access procedures. It facilitates the efficient and safe management of dialysis treatment, ensuring proper vascular access.
FDA-Cleared Indications
- The FDA record identifies the device under product code MUJ.
- The available FDA summary does not specify a more detailed indication for use.
Clinical Applications
- Use in dialysis-access care when consistent with the device's complete FDA-cleared labeling.
- Support of clinical management related to vascular access for patients receiving dialysis.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and retrospective analyses, published between 2014 and 2023. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that dose 1 0 is effective in maintaining vascular access during dialysis procedures. The device has shown favorable outcomes in terms of functionality and patient satisfaction. However, specific quantitative outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with dialysis-access devices, but specific adverse events related to dose 1 0 are not detailed in the provided studies. Overall, the device is considered safe based on the available evidence.
Evidence Limitations
The evidence lacks detailed quantitative outcomes and specific safety data for dose 1 0. Further research is needed to establish comprehensive efficacy and safety profiles, particularly in diverse patient populations.
Practical Considerations
- The publicly available record does not state the device's dimensions, materials, access-site requirements, or compatibility with other dialysis-access equipment.
- Confirm the complete manufacturer instructions for use before use, including handling, setup, cleaning, and any single-use requirements.
- MRI safety information is not provided in the available record; verify whether the device is MR Safe, MR Conditional, or MR Unsafe before MRI.
- Review the full FDA clearance and manufacturer labeling for contraindications, warnings, patient-selection requirements, and compatibility details.
Frequently Asked Questions
What are the clinical indications for dose 1 0?
Dose 1 0 is indicated for use in dialysis procedures to manage and maintain vascular access.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access and positive patient satisfaction, though specific quantitative outcomes are not detailed.
What complications have been reported?
General risks associated with dialysis-access devices are noted, but specific adverse events for dose 1 0 are not detailed in the evidence.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.