# K974584: Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: May 14, 1998 after 157 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 K902837 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971180: Bard NO-Rinse Hemoconcentrator and Accessory Kit, C.R. Bard, Inc. (1997) Summary page 1.
- K902837: Amicon Diafilter 30 Hemoconcentrator, Amicon, Inc. (1990) Summary page 1.
- K923139: Hemocor HP Hemoconcentrator Series, Minntech Corp. (1994) Summary page 1.
- K903641: Quick Prime Hemoconcen. NO. HQ-7000 and CBP-7000Q, Bentley Laboratories, Inc. (1990) Summary page 1.
- K951344: Rmi Hemoconcentrator, Research Medical, Inc. (1995) Summary page 1.
- (no number) Fresenius F40: named in the summary without a submission number
- (no number) Fresenius F60: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K370739: Research Medical Biofilter 140. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K992275: Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/Tubing Set F3000TS (1999), 0 descendants of its own

## Indications for use
The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

Source page: https://510kreport.com/device/K974584
Methodology: https://510kreport.com/methodology