# K082515: Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX

- Pathway: 510(k) (Special)
- Applicant: Asahi Kasei Medical Co., Ltd.
- Decided: Oct 3, 2008 after 31 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001250 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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 1.
- K041726: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EX, Asahi Medical Co., Ltd. (2004) Summary page 1.
- K051187: Rexeed Series Dialyzers, Asahi Kasei Medical Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K121409: Asahi Rexeed-SX/LX Series Dialyzer (2013), 0 descendants of its own

## Recalls of this device
- Sep 21, 2012 · Class II · Z-2418-2012: Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient informati
- Sep 21, 2012 · Class II · Z-2424-2012: Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient informati
- Sep 21, 2012 · Class II · Z-2422-2012: Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient informati
- Sep 21, 2012 · Class II · Z-2420-2012: Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient informati
- Sep 21, 2012 · Class II · Z-2421-2012: Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient informati
- Sep 21, 2012 · Class II · Z-2419-2012: Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient informati
- Sep 21, 2012 · Class II · Z-2423-2012: Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient informati

## Indications for use
REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.

Source page: https://510kreport.com/device/K082515
Methodology: https://510kreport.com/methodology