# K081313: SH14 Hemoconcentrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Nov 19, 2008 after 194 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: 2 generations back to K923139 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951311: Gambro HC 14R Hemoconcentrator, Cobe Renal Care, Inc. (1996) Summary page 1.
- K021732: DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult, Dideco S.P.A. (2002) Summary page 1.

## Most influential descendants
- 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 SH14 hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemoconcentrator depends on the protocol being used and required filtration rate. The device is intended to be used for six hours or less.

Source page: https://510kreport.com/device/K081313
Methodology: https://510kreport.com/methodology