# K983720: Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-Bio-50,AM-Bio-65, AM-Bio-75, and AM-Bio-100, AM-Bio-

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Medical Co., Ltd.
- Decided: May 17, 1999 after 208 days
- Product code: MSE (Hemodialyzer, Re-Use, Low Flux)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Asahi AM Series Dialyzers: named in the summary without a submission number
- (no number) Asahi AM-R Series Dialyzers: named in the summary without a submission number
- (no number) Baxter HT Dialyzers: named in the summary without a submission number
- (no number) Gambro COBE Centrysystem HG Dialyzers: named in the summary without a submission number
- (no number) Gambro Alwall GFS Plus Dialyzers: named in the summary without a submission number

## Most influential descendants
- K013418: AM-Bio Extended Range Series Dialyzer, Models Wet and Dry (2002), 0 descendants of its own

## Recalls of this device
- Oct 12, 2006 · Not classified · Z-0174-2007: 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.
- Oct 12, 2006 · Not classified · Z-0173-2007: 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.
- Mar 31, 2005 · Not classified · Z-0788-05: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

## Indications for use
a. Asahi AM-BIO Series Dialyzers are intended for use for hemodialysts treatment of patients who have chronic renal failure or acute renal failure, b. Asshi AM-BIO Series Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient. c. Asahi AM-BIO Series-Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 13 reuse cycles. Based on the resuits from these evaluations, Asahi AM-BJO 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-BIO 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: 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 these instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., conceming dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed. The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4 ), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialvzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc. The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer. The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiitration controllets.

Source page: https://510kreport.com/device/K983720
Methodology: https://510kreport.com/methodology