510(k) · Cleared
Recalled · Class I · 2026CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · DSP System, Balloon, Intra-Aortic And Control
Cleared on Aug 11, 2003 as substantially equivalent to K965236 (Datascope Corp., 1997) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1997. 7 of the 13 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 8 times, including 5 Class I recalls.
- Decided
- Aug 11, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 8 (5 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K965236 (1997). 2 ancestors in all. 10 later devices descend from it, 3 citing it directly. 7 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK965236 System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · Recalled (Class I)
- This deviceK031636 CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003
- Descendant · cites it directly · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK151254 CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK181122 CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · cites it directly8descendants
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on3descendants
- K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on2descendants
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 3 generations on1descendant
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965236 | System 96 Intra-Aortic Balloon Pump (Iabp) | Datascope Corp. | 1997 | Class I |
| 0 (this device) | K031636 | CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX | Datascope Corp. | 2003 | — |
| +1 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| +2 | K112372 | Cardiosave Hybrid Intra-Aortic Balloon Pump | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | Class I |
| +2 | K112327 | Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | 1 |
| +3 | K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | 2015 | Class I |
| +3 | K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | 2018 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 2 | 1 |
| 2018 | 1 | 1 |
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.
7 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K965236 | System 96 Intra-Aortic Balloon Pump (Iabp)Summary page 1…Pump Commonhsual name: Intra-aortic balloon and control system Classification name: 21 CFR 870.3535 Intra-aortic balloon and control system Predicate Devices: K965236 System 96 Intra-Aortic Balloon Pump K983866 Arrow AutoCAT Intra-Aortic Balloon Pump Device Description: T… | 1997 |
| * | K983866 | Belmont Model Ngpbp Intra-Aortic Balloon PumpSummary page 1…lassification name: 21 CFR 870.3535 Intra-aortic balloon and control system Predicate Devices: K965236 System 96 Intra-Aortic Balloon Pump K983866 Arrow AutoCAT Intra-Aortic Balloon Pump Device Description: The CS 100 Intra-Aortic Balloon Pump ( IABP) is a cardiac assist de… | 2000 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2026 | Class II | Z-1486-2026 | Under Investigation by firm | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. |
| Jul 17, 2017 | Class I | Z-3086-2017 | Under Investigation by firm | False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy. |
| Jul 17, 2017 | Class I | Z-3085-2017 | Under Investigation by firm | False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy. |
| Jun 16, 2017 | Class I | Z-2737-2017 | Component design/selection | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. |
| Jun 16, 2017 | Class I | Z-2736-2017 | Component design/selection | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. |
| Mar 21, 2014 | Class I | Z-1523-2014 | Nonconforming Material/Component | 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 | Device Design | 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. |
| May 10, 2010 | Not classified | Z-1811-2010 | Other | Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to… |
The 5 latest of 8 recalls; the web page lists all.
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.
- K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 3 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
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 inflate and deflate 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.
The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.
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/K031636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031636: CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031636
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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