# K170029: FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corporation
- Decided: Dec 15, 2017 after 345 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852698 (1985). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000) Summary page 5.
- K983272: Ibc Flopump, Model 6000, International Biophysics Corp. (1999) Summary page 5.

## Most influential descendants
- K250632: Arctx Cool Catheter Set (2025), 0 descendants of its own

## Recalls of this device
- Jun 24, 2019 · Class II · Z-0318-2021: The firm has become aware that they have distributed product that was expired.

## Indications for use
The FloPump 32mL 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 i) 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/K170029
Methodology: https://510kreport.com/methodology