# K983272: Ibc Flopump, Model 6000

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Mar 24, 1999 after 188 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: 1 generation back to K852698 (1985). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852698: Bio Medicus Bio Pump Model BP-80, Bio Medicus, Inc. (1985) Summary page 1.

## Most influential descendants
- K170029: FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile (2017), 1 descendant of its own
- K250632: Arctx Cool Catheter Set (2025), 0 descendants of its own
- K031300: Ibc Flopump with GBS Coating (2003), 0 descendants of its own

## Indications for use
The IBC FloPump centrifugal blood pump is indicated for use and is compatible with all models of the Medtronic Bio-Medicus Bio-Consoles to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

Source page: https://510kreport.com/device/K983272
Methodology: https://510kreport.com/methodology