HD-100 Hemodialysis Systems and Accessories
510(k) K863720
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863720 | Date29 Oct 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FIP
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5665
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The HD-100 Hemodialysis Systems and Accessories is a subsystem designed for water purification in hemodialysis treatment. It supports the preparation of dialysate water by removing impurities to ensure safety and efficacy during dialysis procedures. This device is integral to maintaining water quality standards required for renal replacement therapy, particularly in clinical settings where patient safety is paramount.
The HD-100 is intended for use in hemodialysis units, typically operated by nephrologists and dialysis technicians. It is supplied as a reusable system, adhering to regulatory standards outlined under FDA 510(k) clearance (K863720) and classified under regulation 876.5665. The device is not classified as single-use and requires proper maintenance and storage to ensure functionality and compliance with medical-grade water purification protocols. No specific MRI safety information is provided.
Other devices from Water Pure, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the HD-100 Hemodialysis System used for?
The HD-100 is a reusable water purification subsystem designed specifically for hemodialysis. It removes impurities from water to produce dialysate that meets strict safety and efficacy standards required during dialysis treatments. This ensures patients receive reliable, contaminant-free water, which is essential for preventing complications in renal replacement therapy.
Is the HD-100 system single-use or reusable?
The HD-100 is a reusable hemodialysis water purification system. Unlike single-use devices, it is built for repeated use in clinical settings, provided it undergoes proper maintenance and cleaning as outlined in the manufacturer’s guidelines. This design supports long-term reliability in hemodialysis units.
What regulatory approval does the HD-100 hold?
The HD-100 Hemodialysis System and Accessories holds FDA 510(k) clearance under the reference number K863720. This clearance confirms that the device meets U.S. regulatory standards for water purification subsystems in hemodialysis, ensuring its safety and performance for clinical use.
How should the HD-100 system be stored?
The HD-100 must be stored in a clean, dry environment to prevent contamination and maintain functionality. Since it is a reusable system, it should also be disassembled and cleaned according to the manufacturer’s instructions after each use. Proper storage and maintenance are critical to uphold medical-grade water purity and device longevity.
Does the HD-100 have any specific compatibility or maintenance requirements?
The HD-100 is designed for integration into hemodialysis units operated by nephrologists and dialysis technicians. It requires regular maintenance, including cleaning and sanitization, to ensure consistent water purification performance. The system is not classified as single-use, so adherence to the manufacturer’s protocols is essential for compliance with medical-grade water standards.