# K971180: Bard NO-Rinse Hemoconcentrator and Accessory Kit

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 24, 1997 after 115 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Fresenius Hemoflow F40 Capillary Dialyzer: named in the summary without a submission number
- (no number) Bard Hemoconcentrator with Tubing Set, HC70TS: named in the summary without a submission number
- (no number) Research Medical Hemoconcentrator, Biofilter 140: named in the summary without a submission number

## Most influential descendants
- K974584: Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS (1998), 1 descendant of its own
- 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 Bard® No-rinse Hemoconcentrator is intended for the relief or mitigation of overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

Source page: https://510kreport.com/device/K971180
Methodology: https://510kreport.com/methodology