# K133724: Minncare HD

- Pathway: 510(k) (Traditional)
- Applicant: Medivators, Inc.
- Decided: Aug 27, 2014 after 264 days
- Product code: NIH (Disinfectant, Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861730 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023064: Hemoclean, Krd Co., Ltd. (2004) Summary page 5.

## Indications for use
Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20oC.

Source page: https://510kreport.com/device/K133724
Methodology: https://510kreport.com/methodology