# K193663: FloPump 57mL Centrifugal Pump

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corporation
- Decided: Mar 10, 2021 after 435 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011835: Cobe Revolution, Cobe Cardiovascular, Inc. (2002) Summary page 5.

## Indications for use
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Source page: https://510kreport.com/device/K193663
Methodology: https://510kreport.com/methodology