# K050952: HPH Junior High Performance Hemoconcentrator

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Jan 31, 2006 after 291 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: 1 generation back to K980859 (1998). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980859: Hemocor HPH Mini Hemoconcentrator, Minntech Corp. (1998) Summary page 2.

## Most influential descendants
- K071298: HF Junior Hemofilter (2007), 1 descendant of its own
- K123395: Nxstage System One Low Volume Cartridge Express (2013), 0 descendants of its own

## Indications for use
The HPH™ Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. It is indicated for all patients (including all pediatric patients) according to physician assessment of the patient and the Instructions for Use. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.

Source page: https://510kreport.com/device/K050952
Methodology: https://510kreport.com/methodology