# K121409: Asahi Rexeed-SX/LX Series Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Kasei Medical Co., Ltd.
- Decided: Feb 6, 2013 after 271 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001250 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
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 2.
- K082515: Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX, Asahi Kasei Medical Co., Ltd. (2008) Summary page 1.

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

Source page: https://510kreport.com/device/K121409
Methodology: https://510kreport.com/methodology