# K021732: DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult

- Pathway: 510(k) (Traditional)
- Applicant: Dideco S.P.A.
- Decided: Nov 4, 2002 after 164 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.
2 later devices descend from it; 2 cite 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)
- K003023: Cobe HC 700 Midi Hemoconcentrator, Hospal Industrie (2001) Summary page 1.
- K923139: Hemocor HP Hemoconcentrator Series, Minntech Corp. (1994) Summary page 1.

## Most influential descendants
- K081313: SH14 Hemoconcentrator (2008), 1 descendant of its own
- K243264: DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (2025), 0 descendants of its own

## Indications for use
The Dideco DHF Hernoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit The choice of hemconcentrator depends on the protocol being used and required filtration speed -The device is intended to be used for SIX hours or less.

Source page: https://510kreport.com/device/K021732
Methodology: https://510kreport.com/methodology