# K043126: Assist Header Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Alcavis International, Inc.
- Decided: Feb 3, 2005 after 83 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: 2 generations back to K904210 (1990). 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)
- K991851: Renaclear Dialyzer Cleaning System, Minntech Corp. (1999) Summary page 1.

## Indications for use
To aid in the cleaning of the headers, header spaces, and header caps of multiple-use hemodialyzers prior to an approved reprocessing procedure for reusable hemodialyzers.

Source page: https://510kreport.com/device/K043126
Methodology: https://510kreport.com/methodology