# K243264: DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Apr 25, 2025 after 192 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: 3 generations back to K923139 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021732: DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult, Dideco S.P.A. (2002) Summary page 6.
- K081313: SH14 Hemoconcentrator, Sorin Group Italia S.R.L. (2008) Summary page 6.

## Indications for use
The hemoconcentrators are intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient physiological hematocrit. The choice of hemoconcentrator 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/K243264
Methodology: https://510kreport.com/methodology