Cyber 80 Hemodialyzer
by Cyberex Corp. 510(k)
Active
510(k) K810837
Overview
The Cyber 80 Hemodialyzer is a parallel flow dialyzer device used for hemodialysis treatment. It is designed to filter waste products from the blood of patients with kidney failure.
The device is supplied by Cyberex Corp. and is classified as a Class II medical device with FDA 510(k) clearance K810837. It is intended for use in gastroenterology and urology settings, with specific model number K810837 and product code FJG.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810837 | Date5 May 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FJG
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cyberex Corp.
Questions
What clinical conditions is the Cyber 80 Hemodialyzer primarily used to treat, and how does it work?
The Cyber 80 Hemodialyzer is designed to filter waste products from the blood of patients with kidney failure, specifically those requiring hemodialysis. It operates as a parallel flow dialyzer, meaning blood and dialysate flow in parallel channels within the device, allowing efficient removal of toxins and excess fluids while preserving essential blood components. This makes it suitable for patients with end-stage renal disease who rely on dialysis to maintain metabolic balance.
Is the Cyber 80 Hemodialyzer intended for single-use or can it be reused? How should it be handled after use?
The Cyber 80 Hemodialyzer is not explicitly described as single-use or reusable in the provided data. However, hemodialyzers of this type are typically single-use devices due to sterility and contamination risks. After use, it should be disposed of according to infection control protocols and local medical waste regulations to prevent cross-contamination. Always follow manufacturer guidelines or facility policies for proper handling.
What are the key specifications or models associated with this device, and how can I verify its regulatory status?
The Cyber 80 Hemodialyzer is identified by the model number K810837 and product code FJG. It holds FDA 510(k) clearance (K810837) under the Traditional 510(k) review pathway, classified as a Class II device. To verify its regulatory status, you can reference the FDA’s openFDA database or check the FDA’s 510(k) database using the clearance number. The device is also listed under OpenFDA’s dialyzer category (Parallel Flow) with a medical specialty classification for gastroenterology and urology, though this reflects its submission filing category, not clinical indication.
How should the Cyber 80 Hemodialyzer be stored before use, and are there any special handling requirements?
The provided data does not specify storage instructions, but hemodialyzers like this typically require sterile, dry storage in a sealed, protective packaging until use. They should be kept in a clean, temperature-controlled environment (usually room temperature) away from direct sunlight or moisture. Always check the manufacturer’s labeling or instructions for use (IFU) for precise storage guidelines, as improper handling could compromise sterility or performance.