# K013713: Arm Automatic Reprocessing Machine

- Pathway: 510(k) (Traditional)
- Applicant: Alcavis International Incorporated
- Decided: Jul 15, 2002 after 249 days
- Product code: LIF (Dialyzer Reprocessing System)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860674 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860674: DRS-4 Dialyzer Reprocessing System, Seratronics, Inc. (1986) Summary page 1.

## Indications for use
The Amuchina Automatic Reprocessing Machine (ARM) is a device designed for both (a) reprocessing hemodialyzers for reuse, and (b) preprocessing hemodialyzers prior to first use. Reprocessed hemodialyzer will be reused on the same patient on who originally used the hemodialyzer. Both the reprocessing and preprocessing procedures use peracetic acid/hydrogen peroxide based disinfectant.

Source page: https://510kreport.com/device/K013713
Methodology: https://510kreport.com/methodology