# K123288: Hemoconcentrator

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jun 26, 2013 after 247 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 K923139 (1994). 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)
- K983085: Hemocor HPH 700 Hemoconcentrator, Minntech Corp. (1998) Summary page 1.
- K923139: Hemocor HP Hemoconcentrator Series, Minntech Corp. (1994) Summary page 1.

## Indications for use
The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

Source page: https://510kreport.com/device/K123288
Methodology: https://510kreport.com/methodology