510(k) · Cleared
Recalled · Class II · 2024Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Assist, Maquet Cardiovascular, LLC · DSP System, Balloon, Intra-Aortic And Control
Cleared on Sep 9, 2011 as substantially equivalent to K063525 (Datascope Corp., 2007) and 1 other predicate after a 28-day review. Its family tree reaches back 9 generations to 1990. 8 of the 68 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 9, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K892222 (1990). 65 ancestors in all, the oldest K790775 (1979). 2 later devices descend from it, 2 citing it directly. 8 of the 68 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 5 generations between
- 3 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- 2 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 1 generation backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- This deviceK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011
- Descendant · cites it directly · 0 of its ownK133074 Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon…Datascope Corp. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK122628 Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and…Datascope Corp., Cardiac Assist Division · 2012 · Recalled
Show all 9 generations
- Root · 9 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 8 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- 7 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
- 6 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- 5 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
- 4 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
- 3 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- 2 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 1 generation backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- This deviceK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See all- K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp. · 2013 · cites it directly0descendants
- K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −8 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| −7 | K972113 | 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel | Boston Scientific Corp | 1997 | — |
| −6 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| −5 | K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models… | Datascope Corp. | 2000 | — |
| −4 | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC… | Datascope Corp. | 2001 | — |
| −3 | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XX | Datascope Corp. | 2003 | — |
| −2 | K041281 | Datascope 7.5FR. Iab Catheter and Accessories | Datascope Corp. | 2004 | 7 |
| −1 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| 0 (this device) | K112327 | Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | — |
| +1 | K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and… | Datascope Corp. | 2013 | 9 |
| +1 | K122628 | Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and Accessories | Datascope Corp., Cardiac Assist Division | 2012 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Summary page 1…INFORMATION: The SENSATION TM PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is substantially equivalent in function and intended use to the SENSATION® 7Fr. lAB Catheter (K063525) and MEGA TM 8Fr. lAB Catheter (K091 449). DEVICE DESCRIPTION AND INTENDED USE: The SENSATION" PLUS 8 Fr. 50cc lAB Catheter (SEN… | 2007 |
| * | K091449 | Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Summary page 1…50cc Intra-Aortic Balloon Catheter is substantially equivalent in function and intended use to the SENSATION® 7Fr. lAB Catheter (K063525) and MEGA TM 8Fr. lAB Catheter (K091 449). DEVICE DESCRIPTION AND INTENDED USE: The SENSATION" PLUS 8 Fr. 50cc lAB Catheter (SENSATION Plus) is an enhanced SENSATION 7Fr… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 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 · 2 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 · 2 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 · 2 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 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 3 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 21 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 15 of the 65 ancestors have a recall of any class; 8 have a Class I recall.
- Of its descendants, K133074 (Datascope Corp., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063525.
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. 2011, 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?
MAQUET's SENSATION T1.1PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use: * Refractory Unstable Angina. * Impending Infarction. * Acute Myocardial Infarction. * Refractory Ventricular Failure. * Complications of Acute Ml (ie. Acute MR or VSD or papillary muscle rupture) * Cardiogenic Shock. * Support for diagnostic, percutaneous revascularization and interventional procedures. * Ischemia related…
Read the full statement (115 words)
MAQUET's SENSATION T1.1PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use:
* Refractory Unstable Angina.
* Impending Infarction.
* Acute Myocardial Infarction.
* Refractory Ventricular Failure.
* Complications of Acute Ml (ie. 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.
* lntraoperative pulsatile flow generation.
* Weaning from cardiopulmonary 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112327
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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