# K991851: Renaclear Dialyzer Cleaning System

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Aug 30, 1999 after 90 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.
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)
- K904210: Renatron II Dialyzer Reprocessing System RS 8330, Minntech Corp. (1990) Summary page 2.

## Most influential descendants
- K043126: Assist Header Cleaner (2005), 0 descendants of its own

## Indications for use
Minntech Corporation’s RenaClear™ Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers prior to being reprocessed in an approved dialyzer reprocessing program.

Source page: https://510kreport.com/device/K991851
Methodology: https://510kreport.com/methodology