# K982538: Belmont Portable Balloon Pump, Bard Transact Iabp

- Pathway: 510(k) (Special)
- Applicant: Belmont Instrument Corp.
- Decided: Oct 2, 1998 after 73 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915580 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915580: Belmont Model PBP Intra-Aortic Balloon Pump, Belmont Instrument Corp. (1992) Summary page 7.

## Indications for use
There are no changes to the intended use of the IABP for which a 510(k) was approved in October 1992 [510(k) number K915580]. The balloon pump is an electromechanical system used to drive intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.

Source page: https://510kreport.com/device/K982538
Methodology: https://510kreport.com/methodology