# K041726: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EX

- Pathway: 510(k) (Special)
- Applicant: Asahi Medical Co., Ltd.
- Decided: Jul 23, 2004 after 28 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001250 (2000). 1 ancestor in all.
22 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001250: Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models), Asahi Medical Co., Ltd. (2000) Summary page 2.

## Most influential descendants
- K051187: Rexeed Series Dialyzers (2005), 20 descendants of its own
- K082414: Optiflux F250NR, Model 0500325E (2008), 16 descendants of its own
- K123262: Optiflux Ultra Dialyzer (2014), 13 descendants of its own
- K152367: Optiflux dialyzer (2015), 12 descendants of its own
- K162488: Optiflux dialyzer (2017), 9 descendants of its own

## Recalls of this device
- Oct 12, 2006 · Not classified · Z-0171-2007: 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.

## Indications for use
A. APS Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. B. APS Series Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient. C. APS 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 15 reuse cycles. Based on the results from these evaluations, Asahi APS 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 APS 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 these instruction for use and the instruction 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 Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin ® (peroxyacetic acid) in conjunction with the Renatron ® Dialyzer Reprocessing System (RS 8300), 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/K041726
Methodology: https://510kreport.com/methodology