# K970739: Rmi Hemoconcentrator Preference Pack

- Pathway: 510(k) (Traditional)
- Applicant: Research Medical, Inc.
- Decided: Jul 8, 1997 after 130 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 K823338 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823338: Cobe Hemoconcentrator 1.3, Cobe Laboratories, Inc. (1983) Summary page 1.
- K945596: Altres (R) 140 Hemodialyzer, Althin Medical AB an Affiliate of Baxter Intl (1995) Summary page 1.
- K951344: Rmi Hemoconcentrator, Research Medical, Inc. (1995) Summary page 1.
- K961927: Rmi Hemoconcentractor Tubing Set, Research Medical, Inc. (1996) Summary page 1.
- (no number) COBE CV Personalized Hemoconcentration Packs: named in the summary without a submission number
- (no number) COBE CV 3 Liter Waste Bag For Filtrate Collection: named in the summary without a submission number
- (no number) Baxter Bentley HemoCon 1.3: named in the summary without a submission number

## Indications for use
The hemoconcentrator is intended for relief or mitigation of overhydration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.

Source page: https://510kreport.com/device/K970739
Methodology: https://510kreport.com/methodology