# K091360: Clearflux Dialyzer Reprocessing System

- Pathway: 510(k) (Traditional)
- Applicant: Novaflux Technologies
- Decided: Nov 3, 2010 after 544 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 K834447 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860674: DRS-4 Dialyzer Reprocessing System, Seratronics, Inc. (1986) Summary page 2.
- K914580: DRS-4 Dialyzer Reprocessing System, Seratronics, Inc. (1992) Summary page 2.
- K931336: DRS 4 Dialyzer Reprocessing System, Seratronics, Inc. (1996) Summary page 2.
- K904210: Renatron II Dialyzer Reprocessing System RS 8330, Minntech Corp. (1990) Summary page 2.
- K024076: Maky 21.1 Dialyzer Reprocessing System, Hdc Maquinolas, LLC (2003) Summary page 2.
- K834447: Echo MM1000, Mesa Medical, Inc. (1984) Summary page 2.

## Indications for use
The ClearFlux Dialyzer Reprocessing System is indicated for the reprocessing of polysulfone-based high-flux dialyzers for reuse, for preprocessing the dialyzers prior to their assignment to patients for first use, and for tracking the reprocessed dialyzer for use only by the patient to whom the dialyzer was initially assigned. The steps used in reprocessing hemodialyzers with the ClearFlux System include: (1) pre-cleaning, (2) cleaning, (3) rinsing, (4) volume and leak testing, and (5) disinfecting the dialyzers in accordance with the "AAMI Recommended Practice for Reuse of Hemodialyzers." The ClearFlux System performs the patented in-situ two-phase cleaning cycle during reprocessing, which recovers the total cell volume and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers. The ClearFlux Dialyzer Reprocessing System is also indicated for performing record keeping of the dialyzer processing operation. The ClearFlux Dialyzer Reprocessing System is indicated to be used only with the ClearFlux Formula cleaning solution.

Source page: https://510kreport.com/device/K091360
Methodology: https://510kreport.com/methodology