# K970650: Asahi AM-R Series Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Medical Co., Ltd.
- Decided: Sep 30, 1997 after 222 days
- Product code: MSE (Hemodialyzer, Re-Use, Low Flux)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892374 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892374: New AM-Series Dialyzers, Asahi Medical Co., Ltd. (1989) Summary page 3.
- K892375: Modified AM-Series Dialyzers, Asahi Medical Co., Ltd. (1989) Summary page 3.

## Most influential descendants
- K991512: Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-X (1999), 0 descendants of its own

## Indications for use
Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi AM-R Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly: (1) The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of the instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed. (2) The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4™ and DPS4™) manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc. (3) The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer. (4) The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

Source page: https://510kreport.com/device/K970650
Methodology: https://510kreport.com/methodology