# K031300: Ibc Flopump with GBS Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: May 14, 2003 after 20 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: 3 generations back to K922933 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983272: Ibc Flopump, Model 6000, International Biophysics Corp. (1999) Summary page 1.
- K023381: Vision Hollow Fiber Oxygenator with Guardian Coating, Gish Biomedical, Inc. (2003) Summary page 1.

## Indications for use
The IBC FloPump with GBSTMCoating centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio Console0 to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support at flow rates of up to seven (7.0) LPM for periods up to six (6.0) hours.

Source page: https://510kreport.com/device/K031300
Methodology: https://510kreport.com/methodology