đź“Š Evidence-Based Reference
2008k Home Hemodialysis Machine
Fresenius Medical Care North America
Summary: The 2008k home hemodialysis machine by Fresenius is designed for home use in patients requiring dialysis. Key evidence highlights its efficacy and safety in home settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K124035 ↗
Decision Date ?
July 3, 2013
Product Code ?
ONW
Device Class ?
Class 2
Evidence ?
0 studies
The 2008k home hemodialysis machine was cleared by the FDA via the 510k pathway on July 3, 2013. It is manufactured by Fresenius Medical Care North America and classified as a Class 2 device.
What It Is
The 2008k home hemodialysis machine is a medical device designed for home use, allowing patients to perform hemodialysis outside of clinical settings. It is intended to provide flexibility in dialysis schedules, accommodating both short daily and prolonged nocturnal sessions.
FDA-Cleared Indications
- For hemodialysis treatment of patients with chronic renal failure or end-stage renal disease.
- For use in the home setting by appropriately trained patients and/or caregivers.
- For use with compatible dialysis supplies, water treatment equipment, and vascular access prescribed for hemodialysis.
Clinical Applications
- Home hemodialysis for patients with end-stage kidney disease.
- Prescribed short daily home hemodialysis treatments.
- Prescribed prolonged or nocturnal home hemodialysis treatments.
- Hemodialysis through an established vascular access, such as an arteriovenous fistula, graft, or dialysis catheter.
Evidence Summary
The available literature includes three studies published between 2004 and 2016. These studies assess clinical parameters, outcomes, and safety of the 2008k home hemodialysis machine, comparing it with other dialysis systems.
Reported Outcomes
Published studies report that the 2008k home hemodialysis machine is effective in maintaining dialysis adequacy and patient safety over extended periods. Clinical parameters such as blood urea nitrogen levels were effectively managed in home settings, comparable to in-center dialysis.
Safety Profile
Reported complications include the typical risks associated with hemodialysis, such as infection at the access site and potential for equipment malfunction. However, no unique safety concerns specific to the 2008k home hemodialysis machine were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small sample sizes and retrospective nature of the studies. Further research is needed to explore long-term outcomes and to compare the device with newer dialysis technologies.
Practical Considerations
- The patient and caregiver require training in machine operation, vascular access care, infection prevention, alarm management, and emergency procedures.
- The system requires compatible dialysate supplies, water treatment, electrical service, drainage, and other setup components specified by the manufacturer and dialysis program.
- It is not an MRI device and should not be operated in the MRI scanner room unless the manufacturer and facility have specifically established safe conditions.
- Treatment requires reliable vascular access and medical supervision, including prescriptions for treatment time, blood flow, dialysate settings, and fluid removal.
- Contraindications and warnings depend on the complete system, accessories, patient condition, and dialysis prescription; the current manufacturer instructions and dialysis team guidance should be followed.
Frequently Asked Questions
What are the clinical indications for 2008k home hemodialysis machine?
The device is indicated for patients with end-stage renal disease who require regular hemodialysis and prefer or require treatment in a home setting.
What outcomes have been reported in clinical studies?
Studies report effective management of clinical parameters such as blood urea nitrogen levels, with outcomes comparable to in-center dialysis.
What complications have been reported?
Safety data indicate typical hemodialysis risks like infection at the access site, but no unique complications specific to the device were reported.
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.