# K023064: Hemoclean

- Pathway: 510(k) (Traditional)
- Applicant: Krd Co., Ltd.
- Decided: Apr 6, 2004 after 568 days
- Product code: NII (Disinfectant, Dialysate Delivery 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: 1 generation back to K861730 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861730: Actril for Kidney Machine Disinfectant, Renal Systems, Inc. (1987) Summary page 1.

## Most influential descendants
- K133724: Minncare HD (2014), 0 descendants of its own

## Indications for use
HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines). It should be used under the following the dilution rate and contact condition: Hemodialysis Machine Dilution rate Contact time COBE CentrySystem 3 1:9 10 minutes. Nikkiso DBB 22B 1:34 29 minutes. Fresenius 2008K 1:34 15 minutes. Gambro Phoenix 1:25 15 minutes.

Source page: https://510kreport.com/device/K023064
Methodology: https://510kreport.com/methodology