# K120005: ACDS

- Pathway: 510(k) (Special)
- Applicant: Isopure, Corp.
- Decided: Mar 29, 2012 after 86 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920186 (1995). 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)
- K993058: Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill, Pure Water, Inc. (2000) Summary page 1.

## Recalls of this device
- Jul 26, 2022 · Class II · Z-1739-2022: Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
- Apr 19, 2019 · Class II · Z-0821-2020: There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of 

## Indications for use
The Isopure ACDS with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients.

Source page: https://510kreport.com/device/K120005
Methodology: https://510kreport.com/methodology