# K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: May 30, 2008 after 532 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: 3 generations back to K852698 (1985). 13 ancestors in all.
7 later devices descend from it; 3 cite it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991783: AB-180 XC System, Model AB-180XC, Cardiacassist, Inc. (2000) Summary page 4.
- K052570: Tandemheart Transseptal Cannula Set-EF, Model 5140-6221, Cardiacassist, Inc. (2006) Summary page 4.
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 4.
- K924643: Medtronic Bio-Medicus Cannula Insertion Kit, Medtronic Bio-Medicus, Inc. (1992) Summary page 4.
- K050168: Langston Dual Lumen Pressure Monitoring Catheter, Vascular Solutions, Inc. (2005) Summary page 4.

## Most influential descendants
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K093801: Impella Controller (2010), 1 descendant of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own

## Indications for use
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System is intended for partial circulatory support using an extracorporeal bypass control unit. for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements which are useful in determining intravascular pressure.

Source page: https://510kreport.com/device/K063723
Methodology: https://510kreport.com/methodology