# K110845: Impella Controller with Flow Control

- Pathway: 510(k) (Special)
- Applicant: Abiomed, Inc.
- Decided: Apr 27, 2011 after 30 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: 5 generations back to K852698 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093801: Impella Controller, Abiomed, Inc. (2010) Summary page 1.

## Indications for use
The IMPELLA Controller with Flow Control is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller with Flow Control is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments. The IMPELLA Controller with Flow Control also displays pressure measurement readings, which are useful in determining intravascular pressure.

Source page: https://510kreport.com/device/K110845
Methodology: https://510kreport.com/methodology