510(k) · Cleared
Recalled · Class II · 2024Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and Accessories
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 Dec 12, 2013 as substantially equivalent to K091449 (Datascope Corp., Cardiac Assist Division, 2009) and 1 other predicate after a 73-day review. Its family tree reaches back 10 generations to 1990. 8 of the 67 devices in its family, counting itself, have a Class I recall. It has been recalled 9 times.
- Decided
- Dec 12, 2013
- Review
- 73 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 10 generations to K892222 (1990). 66 ancestors in all, the oldest K790775 (1979). No later device cites it as a predicate yet. 8 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 6 generations between
- 3 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 2 generations backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- 1 generation backK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled
- This deviceK133074 Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon…Datascope Corp. · 2013
Show all 10 generations
- Root · 10 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 9 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- 8 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
- 7 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- 6 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
- 5 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
- 4 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- 3 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 2 generations backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- 1 generation backK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled
- This deviceK133074 Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon…Datascope Corp. · 2013
Class I recalls in this family
- K063525 Datascope Fiber Optic Pressure Sensor…2 generations back · 2007
- K060309 Autocat Intra-Aortic Balloon Pump Series3 generations back · 2006
- K031636 CS100 Intra-Aortic Balloon Pump, Model…3 generations back · 2003
- K021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a…3 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −9 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| −8 | K972113 | 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel | Boston Scientific Corp | 1997 | — |
| −7 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| −6 | K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models… | Datascope Corp. | 2000 | — |
| −5 | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC… | Datascope Corp. | 2001 | — |
| −4 | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XX | Datascope Corp. | 2003 | — |
| −3 | K041281 | Datascope 7.5FR. Iab Catheter and Accessories | Datascope Corp. | 2004 | 7 |
| −2 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| −1 | K112327 | Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | 1 |
| 0 (this device) | K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and… | Datascope Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 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 |
| 2009 | 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.
8 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 |
|---|---|---|---|
| * | K091449 | Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Summary page 1…ct Code: DSP PREDICATE DEVICE INFORMATION: The enhanced 8Fr. Introducer Set is substantially equivalent to the BFr. Introducer Set packaged in the MEGA (K091449) and SENSATION PLUS (K1 12327) 8Fr. 50cc lntra-Aortic Balloon (lAB) Catheters and Accessories predicate devices. DEVICE DESCRIPTI… | 2009 |
| * | K112327 | Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesSummary page 1…PREDICATE DEVICE INFORMATION: The enhanced 8Fr. Introducer Set is substantially equivalent to the BFr. Introducer Set packaged in the MEGA (K091449) and SENSATION PLUS (K1 12327) 8Fr. 50cc lntra-Aortic Balloon (lAB) Catheters and Accessories predicate devices. DEVICE DESCRIPTION AND INTENDED USE: The 8Fr.… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2024 | Class II | Z-0311-2025 | Error in labeling | There is discrepant labeling on the inner and outer packaging of the device. |
| Jun 23, 2023 | Class II | Z-2222-2023 | 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… |
| Jun 23, 2023 | Class II | Z-2220-2023 | 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… |
| Aug 5, 2022 | Class II | Z-1687-2022 | Vendor change control | Certain lots containing undersized dilator. |
| Aug 5, 2022 | Class II | Z-1686-2022 | Vendor change control | Certain lots containing undersized dilator. |
| Aug 5, 2022 | Class II | Z-1685-2022 | Vendor change control | Certain lots containing undersized dilator. |
| Jul 27, 2020 | Class II | Z-2837-2020 | Process change control | Potential Endotoxin Contamination |
| Feb 21, 2018 | Class II | Z-1385-2018 | Error in labeling | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section. |
| Apr 12, 2017 | Class II | Z-2164-2017 | Device Design | Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION… |
The 5 latest of 9 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.
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 128 Class I recalls
- K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · 3 generations back · ◆ 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 · 3 generations back · ◆ 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 · 3 generations back · ◆ 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 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 16 of the 66 ancestors have a recall of any class; 8 have a Class I recall.
- 1 other device also cites its predicate K091449.
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. 2013, 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?
The MESA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have the following Indications for use: * Refractory Unstable Angina. * Impending Infarction. * Acute Myocardial Infarction. * Refractory Ventricular Failure. * Complications of Acute MI (ie.Acute MR or VSD or papillary muscle rupture) * Cardiogenic Shock. * Support for diagnostic, percutaneous revascularization and Interventionall procedures. * Isohemia misated…
Read the full statement (116 words)
The MESA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have the following Indications for use:
* Refractory Unstable Angina.
* Impending Infarction.
* Acute Myocardial Infarction.
* Refractory Ventricular Failure.
* Complications of Acute MI (ie.Acute MR or VSD or papillary muscle rupture)
* Cardiogenic Shock.
* Support for diagnostic, percutaneous revascularization and Interventionall procedures.
* Isohemia misated Intractable ventricular arrhythmlas.
* Septic Shock.
* Inireoperatie pulsatile flow generation.
* Weaning from cardiopulmonary bypass.
* Cardiac support for non-cardiac surgery.
* Prophylactic support in preparation for cardiac surgery.
* Post-surgical myocardial dysfunctionlow 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/K133074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133074: Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133074
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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