# K093801: Impella Controller

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Jul 8, 2010 after 210 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: 4 generations back to K852698 (1985). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System, Abiomed, Inc. (2008) Summary page 1.

## Most influential descendants
- K110845: Impella Controller with Flow Control (2011), 0 descendants of its own

## Indications for use
The IMPELLA Controller 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 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 also displays pressure measurement readings, which are useful in determining intravascular pressure.

Source page: https://510kreport.com/device/K093801
Methodology: https://510kreport.com/methodology