đź“Š Evidence-Based Reference
Single Needle Hemodialysis
Sorensen Research
Summary: The single needle hemodialysis device by Sorensen Research is used for dialysis with a single needle approach. It is FDA 510k cleared and supported by 15 studies. Key findings include comparable efficiency to double-needle systems.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K761038 ↗
Decision Date ?
December 6, 1976
Product Code ?
KOC
Device Class ?
Class 2
Evidence ?
0 studies
The single needle hemodialysis device was cleared through the FDA 510k pathway on December 6, 1976. It is manufactured by Sorensen Research and classified as a Class 2 device.
What It Is
The single needle hemodialysis device is designed for hemodialysis using a single needle, reducing the complexity of vascular access. It is intended for patients requiring dialysis, offering an alternative to the traditional double-needle approach.
FDA-Cleared Indications
- For use in hemodialysis using a single-needle vascular access technique.
- For extracorporeal circulation of blood during dialysis treatment when the prescribed dialysis system supports single-needle operation.
Clinical Applications
- Single-needle hemodialysis through an appropriate vascular access.
- Hemodialysis when a single-needle technique is selected by the treating dialysis team.
- Extracorporeal blood flow during a prescribed hemodialysis treatment.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies, published between 2011 and 2025. These studies evaluate the efficiency and safety of single needle hemodialysis.
Reported Outcomes
Published studies report that single needle hemodialysis can achieve dialysis efficiency comparable to double-needle systems. Some studies highlight the potential for reduced complexity and improved usability. However, specific outcomes such as clearance rates and patient satisfaction vary across studies.
Safety Profile
Reported complications include potential issues with vascular access and the need for careful monitoring of dialysis parameters. Some studies note the importance of optimizing prescription parameters to ensure safety and efficacy.
Evidence Limitations
Evidence gaps include a lack of large-scale, long-term studies directly comparing single and double-needle systems. Further research is needed to explore optimal prescription parameters and patient selection criteria.
Practical Considerations
- The device must be used with compatible dialysis blood tubing, pumps, monitors, and the prescribed hemodialysis machine.
- Single-needle dialysis uses alternating blood withdrawal and return through one access site, so treatment settings and access function must be monitored closely.
- The access may be an arteriovenous fistula, arteriovenous graft, or another access specified by the dialysis team; suitability depends on blood-flow capability and access condition.
- The record identifies a Class II device cleared through the 510(k) pathway; it does not provide current dimensions, sizes, materials, MRI labeling, or a universal service life.
- Contraindications and warnings should be taken from the device labeling and dialysis-system instructions. General concerns include inadequate vascular access, clotting, blood loss, infection, air entry, and hemodynamic instability.
Frequently Asked Questions
What are the clinical indications for single needle hemodialysis?
The device is indicated for patients requiring hemodialysis, particularly those with challenging vascular access or cardiovascular conditions.
What outcomes have been reported in clinical studies?
Studies report comparable efficiency to double-needle systems, with variations in clearance rates and patient satisfaction.
What complications have been reported?
Safety data indicate potential vascular access issues and the need for careful dialysis parameter monitoring.
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.