# K983085: Hemocor HPH 700 Hemoconcentrator

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Nov 13, 1998 after 71 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hemocor HPH® 1000 Hemoconcentrator: named in the summary without a submission number

## Most influential descendants
- K123288: Hemoconcentrator (2013), 0 descendants of its own

## Recalls of this device
- Aug 18, 2015 · Class II · Z-2735-2015: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone device
- Aug 3, 2015 · Class II · Z-2761-2015: Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.

## Indications for use
The Hemocor HPH 700 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.

Source page: https://510kreport.com/device/K983085
Methodology: https://510kreport.com/methodology