# K965236: System 96 Intra-Aortic Balloon Pump (Iabp)

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Jul 1, 1997 after 182 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
7 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031636: CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX (2003), 10 descendants of its own
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), 3 descendants of its own
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories (2011), 2 descendants of its own
- K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (2015), 1 descendant of its own

## Recalls of this device
- Mar 21, 2014 · Class I · Z-1523-2014: Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
- Mar 16, 2011 · Not classified · Z-2414-2011: Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.

## Indications for use
The following are the indications for use for the System 96 Intra Aortic Balloon Pump: Refractory Ischemia Myocardial Infarction Preoperative Hemodynamic Stability Weaning from Cardio Pulmonary Bypass Refractory Ventricular Failure Cardiogenic Shock Unstable Refractory Angina Septic Shock Angioplasty Support Intraoperative Pulsatile Flow Generation Any other uses are not recognized by Datascope Corporation as bonafide.

Source page: https://510kreport.com/device/K965236
Methodology: https://510kreport.com/methodology