510(k) · Cleared
ClearedBelmont Model Ngpbp Intra-Aortic Balloon Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belmont Instrument Corp. · DSP System, Balloon, Intra-Aortic And Control
Cleared on Jan 6, 2000 after a 430-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 9 of the 20 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it.
- Decided
- Jan 6, 2000
- Review
- 430 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 1
19 later devices descend from it, 3 citing it directly. 9 of the 20 devices in this family, counting this one, have a Class I recall.
- This deviceK983866 Belmont Model Ngpbp Intra-Aortic Balloon PumpBelmont Instrument Corp. · 2000
- Descendant · cites it directly · 17 of its ownK002256 Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc. · 2001
- Descendant · cites it directly · 14 of its ownK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Recalled (Class I)
- Descendant · cites it directly · 10 of its ownK031636 CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK162820 AC3 Series IABP SystemArrow International, Inc. · 2017 · Recalled (Class I)
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 19 · See all- K002256Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc. · 2001 · cites it directly17descendants
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · cites it directly14descendants
- K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · cites it directly10descendants
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · 2 generations on8descendants
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983866 | Belmont Model Ngpbp Intra-Aortic Balloon Pump | Belmont Instrument Corp. | 2000 | — |
| +1 | K002256 | Arrow Acat 2 Intra-Aortic Balloon Pump | Arrow Intl., Inc. | 2001 | — |
| +1 | K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | 2006 | Class I |
| +1 | K031636 | CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX | Datascope Corp. | 2003 | Class I |
| +2 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| +2 | K162820 | AC3 Series IABP System | Arrow International, Inc. | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2006 | 1 | 1 |
| 2007 | 2 | 1 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 3 | 2 |
| 2018 | 1 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 1 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
9 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSP device
- #1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 15 Class I recalls
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 128 Class I recalls
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 111 Class I recalls
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- Of its descendants, K002256 (Arrow Intl., Inc., 2001) has gone furthest, with 17 descendants of its own.
How does its category compare?
All DSP devicesDSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSP
140in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSP
4in 2025
Class I (47 since 2007) Class II/III not classified
Adverse event reports per year · DSP
7,422in 2025
MAUDE reports naming product code DSP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 461 |
| 2008 | 0 | — | 0 | 617 |
| 2009 | 2 | — | 14 | 656 |
| 2010 | 0 | — | 8 | 1,019 |
| 2011 | 2 | — | 0 | 590 |
| 2012 | 2 | — | 3 | 490 |
| 2013 | 1 | — | 0 | 495 |
| 2014 | 0 | — | 1 | 1,738 |
| 2015 | 1 | — | 0 | 404 |
| 2016 | 0 | — | 9 (9) | 419 |
| 2017 | 3 | 73 | 0 | 2,164 |
| 2018 | 1 | — | 2 (2) | 3,331 |
| 2019 | 3 | 140 | 3 | 3,552 |
| 2020 | 2 | — | 0 | 3,393 |
| 2021 | 0 | — | 5 (3) | 4,345 |
| 2022 | 0 | — | 33 (33) | 5,113 |
| 2023 | 1 | — | 0 | 6,980 |
| 2024 | 0 | — | 1 | 7,317 |
| 2025 | 1 | — | 4 | 7,422 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983866 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983866: Belmont Model Ngpbp Intra-Aortic Balloon Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983866
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026