# K974652: Blood Monitor Pump with Ultrafiltration Controller

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 10, 1998 after 210 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911315 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970591: Blood Monitor Pump, Baxter Healthcare Corp (1997) Summary page 1.
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997) Summary page 1.

## Recalls of this device
- Dec 21, 2005 · Not classified · Z-0679-06: Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubi

## Indications for use
The bm 25 Blood Monitor Pump with Ultrafiltration Controller is indicated for continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload as prescribed by a physician.

Source page: https://510kreport.com/device/K974652
Methodology: https://510kreport.com/methodology