# K071298: HF Junior Hemofilter

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Aug 8, 2007 after 91 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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 K980859 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962707: Minntech Minnifilter Plus Hemofilter and Tubing Set, Minntech Corp. (1996) Summary page 2.
- K050952: HPH Junior High Performance Hemoconcentrator, Minntech Corp. (2006) Summary page 2.

## Most influential descendants
- K123395: Nxstage System One Low Volume Cartridge Express (2013), 0 descendants of its own

## Indications for use
The HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, bums, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to reduce fluid overload. In hypercatabolic patients requiring more intensive solute removal, a sterile dialysate fluid may be made to flow around the fibers via the dialysate ports in order to increase the clearance of small molecules. It is indicated for patients (including pediatric patients) according to physician assessment of the patient and the instructions for use.

Source page: https://510kreport.com/device/K071298
Methodology: https://510kreport.com/methodology