# K992592: A-Miniature Centrifugal Blood Pump System, Model CPB 2000

- Pathway: 510(k) (Traditional)
- Applicant: A-Med Systems, Inc.
- Decided: May 4, 2000 after 276 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852698 (1985). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852807: Bio Medicus Bio Pump Model BP-50, Bio Medicus, Inc. (1985) Summary page 4.
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 4.
- K901584: Bio-Medicus Bio Console Models 540 a B C, Bio Medicus, Inc. (1990) Summary page 4.
- K950739: 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System, 3M Health Care, Sarns (1995) Summary page 4.

## Most influential descendants
- K020529: Large Centrifugal Blood Pump, Model CP-2 (2002), 0 descendants of its own
- K013393: Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1H (2001), 0 descendants of its own

## Indications for use
The A-Med Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

Source page: https://510kreport.com/device/K992592
Methodology: https://510kreport.com/methodology