# K983866: Belmont Model Ngpbp Intra-Aortic Balloon Pump

- Pathway: 510(k) (Traditional)
- Applicant: Belmont Instrument Corp.
- Decided: Jan 6, 2000 after 430 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
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
9 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K913580: Belmont Model PBP Intra-Aortic Balloon Pump. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K002256: Arrow Acat 2 Intra-Aortic Balloon Pump (2001), 17 descendants of its own
- K060309: Autocat Intra-Aortic Balloon Pump Series (2006), 14 descendants of its own
- 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
- K162820: AC3 Series IABP System (2017), 4 descendants of its own

## Indications for use
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/K983866
Methodology: https://510kreport.com/methodology