510(k) · Cleared
Recalled · Class I · 2026Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System
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 Jan 5, 2007 as substantially equivalent to K041281 (Datascope Corp., 2004) and 7 other predicates after a 44-day review. Its family tree reaches back 8 generations to 1990. 12 of the 71 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 10 times, including a Class I recall.
- Decided
- Jan 5, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 10 (1 Class I)
- Predicates
- 8
Its longest line of descent runs back 8 generations to K892222 (1990). 62 ancestors in all, the oldest K790775 (1979). 8 later devices descend from it, 3 citing it directly. 12 of the 71 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 7 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- 6 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
- 5 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- 4 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
- 3 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
- 2 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- 1 generation backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- This deviceK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007
- Descendant · cites it directly · 3 of its ownK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK151254 CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK181122 CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK172305 CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon…Datascope Corp. · 2017 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · cites it directly3descendants
- K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 2011 · cites it directly2descendants
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 2 generations on1descendant
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 2 generations on0descendants
- K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −7 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| −6 | K972113 | 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel | Boston Scientific Corp | 1997 | — |
| −5 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| −4 | K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models… | Datascope Corp. | 2000 | — |
| −3 | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC… | Datascope Corp. | 2001 | — |
| −2 | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XX | Datascope Corp. | 2003 | — |
| −1 | K041281 | Datascope 7.5FR. Iab Catheter and Accessories | Datascope Corp. | 2004 | 7 |
| 0 (this device) | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | — |
| +1 | K112372 | Cardiosave Hybrid Intra-Aortic Balloon Pump | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | Class I |
| +1 | K112327 | Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | 1 |
| +2 | K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | 2015 | Class I |
| +2 | K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | 2018 | Class I |
| +1 | K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | Datascope Corp. | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 1 |
| 1998 | 4 | 1 |
| 2000 | 5 | 2 |
| 2001 | 1 | 0 |
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
| 2004 | 1 | 0 |
| 2006 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
12 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? (8)
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 |
|---|---|---|---|
| * | K041281 | Datascope 7.5FR. Iab Catheter and AccessoriesSummary page 1…and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is substantially equivalent to the following marketed devices: * K041281 - Datascope's Linear 7.5Fr. LAB, Substantially Equivalent 6/07/04 * K031636 - Data… | 2004 |
| * | K031636 | CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXSummary page 1…following marketed devices: * K041281 - Datascope's Linear 7.5Fr. LAB, Substantially Equivalent 6/07/04 * K031636 - Datascope's CS 100 lAB Pump, Substantially Equivalent 8/11/03 · K031569 - Datasco… | 2003 |
| * | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XXSummary page 1…Equivalent 6/07/04 * K031636 - Datascope's CS 100 lAB Pump, Substantially Equivalent 8/11/03 · K031569 - Datascope's 8Fr. lAB, Substantially Equivalent 6/10/03… | 2003 |
| * | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Summary page 2…ially Equivalent 6/10/03 - - · K013326 - Datascope's Fidelity 8Fr. IAB, Substantially Equivalent 11/02/01 * K060309- Arrow AutoCAT Intra… | 2001 |
| * | K060309 | Autocat Intra-Aortic Balloon Pump SeriesSummary page 2…- - · K013326 - Datascope's Fidelity 8Fr. IAB, Substantially Equivalent 11/02/01 * K060309- Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, Substantially Equivalent 4/06/06 * K04080… | 2006 |
| * | K040801 | Intra-Aortic Balloon (Iab)Summary page 2…Equivalent 11/02/01 * K060309- Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, Substantially Equivalent 4/06/06 * K040801 - Arrow International's Intra-Aortic Balloon Catheter, Substantially Equivalent 5/06/04 * K021462… | 2004 |
| * | K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…Summary page 2…antially Equivalent 4/06/06 * K040801 - Arrow International's Intra-Aortic Balloon Catheter, Substantially Equivalent 5/06/04 * K021462 - Arrow International's lAB Fiber Optic Sensor (FOS)/FOS Measurement System, Substantially… | 2002 |
| * | K981660 | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersSummary page 2…462 - Arrow International's lAB Fiber Optic Sensor (FOS)/FOS Measurement System, Substantially Equivalent 6/06/02 * K981660 Arrow International (C.R. Bard, Inc.) 8Fr 40 cc and 7Fr. 30 cc Sheathless lntra-Aortic Balloon… | 1998 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2026 | Class II | Z-1487-2026 | 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. |
| Jun 23, 2023 | Class II | Z-2217-2023 | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization… |
| Jul 27, 2020 | Class II | Z-2835-2020 | Process change control | Potential Endotoxin Contamination |
| Jul 27, 2020 | Class II | Z-2834-2020 | Process change control | Potential Endotoxin Contamination |
| Dec 16, 2014 | Class II | Z-1062-2015 | Device Design | Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become… |
| 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-1812-2010 | 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… |
| Feb 4, 2009 | Not classified | Z-1198-2009 | Process design | Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor. |
| Nov 19, 2007 | Not classified | Z-0567-2008 | Other | Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display… |
The 5 latest of 10 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.
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 128 Class I recalls
- K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 15 Class I recalls
- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersC.R. Bard, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
- K000729Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 2 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 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 62 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K112372 (Cardiac Assist, Maquet Cardiovascular, LLC, 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K041281.
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. 2007, this device’s year, is highlighted.
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?
CS300 Intra-Aortic Balloon Pump has the following indications for use: 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…
Read the full statement (221 words)
CS300 Intra-Aortic Balloon Pump has the following indications for use:
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.
Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:
* Refractory unstable angina
* Impending infarction
* Acute MI
* Refractory ventricular failure
* Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)
* Cardiogenic shock
* Support for diagnostic, percutaneous revascularization, and interventional procedures
* Ischemia related intractable ventricular arrhythmias
* Septic shock
* Intraoperative pulsatile flow generation
* Weaning from bypass
* Cardiac support for non-cardiac surgery
* Prophylactic support in preparation for cardiac surgery
* Post surgical myocardial dysfunction/low cardiac output syndrome
* Myocardial contusion
* Mechanical bridge to other assist devices
* Cardiac support following correction of anatomical defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063525
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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