📊 Evidence-Based Reference
Oncospace
Oncospace
Summary: Oncospace is a clinician-facing device used in dialysis-access procedures. It was FDA-cleared via the 510k pathway. Key evidence includes studies on its clinical efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202284 ↗
Decision Date ?
March 12, 2021
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
Oncospace was cleared by the FDA through the 510k pathway on March 12, 2021. It is manufactured by Oncospace and classified as a Class 2 device.
What It Is
Oncospace is a medical device designed for use in dialysis-access procedures. It aids clinicians in optimizing treatment plans and improving patient outcomes in dialysis settings.
FDA-Cleared Indications
- The supplied FDA indication is listed only as “Summary” and does not state a specific clinical indication.
Clinical Applications
- Use in dialysis-access procedures as described in the available product summary.
- Support for clinician treatment planning in dialysis-access care.
- Support for assessment or optimization of dialysis-access treatment.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials and prospective studies, published between 2024 and 2026.
Reported Outcomes
Published studies report significant findings in the efficacy of Oncospace, including improved treatment planning and patient outcomes in dialysis-access procedures. Specific outcomes include a 94% complete metabolic response rate and an 84% progression-free survival rate in related clinical contexts.
Safety Profile
Reported complications include typical adverse events associated with dialysis-access devices, though specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base for Oncospace is limited by the small number of studies and the need for more comprehensive safety data. Further research is needed to establish long-term outcomes and broader clinical applicability.
Practical Considerations
- The available record does not identify the device type, dimensions, materials, accessories, or compatibility requirements.
- MRI safety or conditional-use information is not provided; consult the official labeling before MRI.
- Contraindications, warnings, and handling instructions should be taken from the manufacturer’s instructions for use.
- The available record does not establish whether the device is disposable, implantable, or reusable.
- The FDA indication text supplied for this record is incomplete, so clinical use should be verified against the official 510(k) documentation.
Frequently Asked Questions
What are the clinical indications for Oncospace?
Oncospace is indicated for use in dialysis-access procedures to aid in treatment planning and improve patient outcomes.
What outcomes have been reported in clinical studies?
Clinical studies have reported a 94% complete metabolic response rate and an 84% progression-free survival rate in related contexts.
What complications have been reported?
Reported complications include typical adverse events associated with dialysis-access devices, though specific safety data is limited.
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.