# K013418: AM-Bio Extended Range Series Dialyzer, Models Wet and Dry

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Medical Co., Ltd.
- Decided: Jul 9, 2002 after 267 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 K892262 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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-, Asahi Medical Co., Ltd. (1999) Summary page 1.
- K001250: Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models), Asahi Medical Co., Ltd. (2000)
- K892262: Fresenius Hemoflow, F40M, F50M, F60M & F80M, Fresenius USA, Inc. (1989) Summary page 1.

## Recalls of this device
- Mar 31, 2005 · Not classified · Z-0789-05: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

## Indications for use
a. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. b. Asahi AM-BIO Extended Range (AM-BIO-HX 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 Extended Range (AM-BIO-HX series) Dialyzers are intended for single use only. d. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are designed only to be used only on dialysis systems equipped with volumetric ultrafiltration controllers. e. The expiration date of ASAHI AM-BIO Extended Range (AM-BIO-HX series) Dialyzers is 3 years from the sterilization date. The user must use the dialyzers before the expiration date.

Source page: https://510kreport.com/device/K013418
Methodology: https://510kreport.com/methodology