# K033505: Renaclean SH Dialyzer Cleaning System

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Apr 27, 2004 after 174 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 K904210 (1990). 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)
- K904210: Renatron II Dialyzer Reprocessing System RS 8330, Minntech Corp. (1990) Summary page 1.

## Indications for use
Minntech Corporation's RenaClean T M SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron®Dialyzer Reprocessing System.

Source page: https://510kreport.com/device/K033505
Methodology: https://510kreport.com/methodology