Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-X
510(k) K991512
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991512 | Date29 Jul 1999 | StatusActive |
Recalls
-
- Terminated Z-0175-2007
There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FJI
- 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 Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-X, are Dialyzer, Capillary, Hollow Fiber devices designed for hemodialysis. These devices utilize cuprammonium rayon membranes to facilitate the removal of waste products and excess fluids from the blood of patients with chronic or acute renal failure. The hollow fiber structure enables efficient filtration while maintaining biocompatibility and mechanical stability during dialysis sessions.
These dialyzers are intended for reprocessing and reuse on the same patient, adhering to regulatory standards for Class II medical devices under product code FJI. Supplied sterile, they are used in clinical settings such as nephrology units and dialysis centers. The device’s specifications align with FDA clearance (K991512) and are classified under special controls for hemodialysis applications, ensuring compliance with regulatory requirements for patient safety and device performance.