# K970591: Blood Monitor Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 9, 1997 after 203 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: 1 generation back to K911315 (1991). 1 ancestor in all.
1 later device descends 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)
- K911315: Extracorporeal Blood Pumping Syst for Hemofiltrat, Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K974652: Blood Monitor Pump with Ultrafiltration Controller (1998), 0 descendants of its own

## Recalls of this device
- Dec 21, 2005 · Not classified · Z-0680-06: 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 bm11a Blood Monitor Pump is designed for continuous renal replacement therapy in patients with acute renal failure, as prescribed by a physician.

Source page: https://510kreport.com/device/K970591
Methodology: https://510kreport.com/methodology