# K963203: Bentley Quick-Prime Hemoconcentrator with Duraflo Treatment

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 25, 1997 after 222 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Quick-Prime Hemoconcentrators (HQ-7000™, HQ-7005™ with tubing set, and HQ-7005L™ with tubing set/male luer adapters): named in the summary without a submission number

## Indications for use
The Quick-Prime Hemoconcentrator is designed for use in cardiopulmonary bypass surgery to remove excess fluid and low molecular weight blood constituents from the extracorporeal circuit. It is also indicated for use for patients with acute or chronic fluid overload when conservative therapy is inadequate.

Source page: https://510kreport.com/device/K963203
Methodology: https://510kreport.com/methodology