FloPump 57mL Centrifugal Pump

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K193663 ↗

FDA Product Code

KFM

FDA applicant

International Biophysics Corporation

Device Class

Class II

Regulation

21 CFR Part 870.4360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from International Biophysics Corp. →

• What clinical settings is the FloPump 57mL Centrifugal Pump intended for use in, and how long can it be used for in those settings?

  The FloPump 57mL Centrifugal Pump is designed for short-term use (less than six hours) in controlled clinical environments such as operating rooms or cardiac catheterization labs. Its non-roller centrifugal design ensures continuous blood circulation in cardiopulmonary bypass circuits, making it suitable for procedures requiring precise, reliable perfusion during critical interventions.

• Is the FloPump 57mL Centrifugal Pump intended for single-use or reusable applications, and how should it be stored to maintain sterility?

  The FloPump 57mL Centrifugal Pump is supplied sterile and intended for single-use only. To preserve sterility and functionality, it must be stored and handled according to the manufacturer’s instructions, which likely include keeping it in its original packaging until use and avoiding exposure to contaminants or environmental conditions that could compromise its integrity.

• What regulatory pathway was followed for FDA clearance of the FloPump 57mL Centrifugal Pump, and what classification does it hold?

  The FloPump 57mL Centrifugal Pump received FDA clearance through a 510(k) premarket notification process, classified as a Class II medical device under 21 CFR 870.4360 with the product code KFM. The clearance was granted by the FDA’s Cardiovascular (CV) Advisory Committee and is considered substantially equivalent to predicate devices, ensuring it meets established safety and performance standards for non-roller blood pumps in cardiopulmonary bypass applications.

• How does the FloPump 57mL Centrifugal Pump differ from traditional roller-pump systems, and what advantages does its design offer?

  Unlike roller-pump systems, the FloPump 57mL Centrifugal Pump uses centrifugal force to propel blood through an extracorporeal circuit, eliminating mechanical rollers that can cause hemolysis or shear stress. This design reduces the risk of blood trauma, provides smoother flow, and is particularly suited for short-term procedures where reliability and minimal blood damage are critical. Its simplicity also lowers maintenance requirements compared to roller-based systems.