Automatic Dialyzer Reprocessor ADR-22
by Texas Medical Devices, Inc.
510(k) K820695
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820695 | Date29 Apr 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Automatic Dialyzer Reprocessor ADR-22 is a Dialyzer Reprocessing System, designed to clean, disinfect, and prepare used hemodialysis membranes for reuse. This device adheres to regulatory standards for reprocessing dialyzers, ensuring compliance with medical specialty requirements for gastroenterology and urology applications. It is classified under FDA regulation 876.5820 as a Class II medical device, requiring strict adherence to reprocessing protocols to maintain patient safety and device efficacy.
The ADR-22 is intended for use in clinical dialysis settings, where it reprocesses single-use dialyzers to extend their utility while maintaining sterility and performance standards. Supplied as a reusable system, it requires proper training and adherence to manufacturer guidelines for cleaning, disinfection, and storage. The device holds FDA 510(k) clearance (K820695) and is regulated under product code LIF, ensuring it meets established safety and effectiveness criteria for reprocessed hemodialysis equipment.
Questions
AI-generated answers, 1 Oct 2026
What is the Automatic Dialyzer Reprocessor ADR-22 used for?
The ADR-22 is designed to clean, disinfect, and prepare used hemodialysis membranes for safe reuse in clinical settings. This extends the lifespan of single-use dialyzers while ensuring they meet performance and sterility standards required for patient safety during dialysis procedures.
Is the ADR-22 a single-use or reusable device?
The ADR-22 is a reusable system. It is intended for repeated use in reprocessing dialyzers, provided it is maintained according to the manufacturer’s guidelines for cleaning, disinfection, and storage to ensure consistent safety and efficacy.
What regulatory approvals does the ADR-22 hold?
The ADR-22 holds FDA 510(k) clearance (K820695) and is classified under FDA regulation 876.5820 as a Class II medical device. This classification ensures it adheres to strict reprocessing protocols for hemodialysis equipment, meeting established safety and effectiveness criteria.
Which medical specialties benefit from the ADR-22?
The ADR-22 is primarily regulated under advisory committees for gastroenterology and urology, though its core application lies in hemodialysis settings. Its reprocessing capabilities support patient care in clinical dialysis programs where dialyzer reuse is practiced.
How is the ADR-22 supplied and stored?
The ADR-22 is supplied as a reusable system and requires proper training for operation. It must be stored in a clean, dry environment following manufacturer guidelines to prevent contamination and ensure longevity. Regular maintenance, including cleaning and disinfection cycles, is essential for optimal performance.