510(k) · Cleared
ClearedDatascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp., Cardiac Assist Division · DSP System, Balloon, Intra-Aortic And Control
Cleared on Jun 18, 2009 as substantially equivalent to K041281 (Datascope Corp., 2004) and 3 other predicates after a 31-day review. Its family tree reaches back 8 generations to 1990. 3 later devices descend from it.
- Decided
- Jun 18, 2009
- Review
- 31 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K892222 (1990). 46 ancestors in all, the oldest K790775 (1979). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK091449 Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories…Datascope Corp., Cardiac Assist Division · 2009
- 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 · cites it directly · 0 of its ownK133074 Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon…Datascope Corp. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK122628 Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and…Datascope Corp., Cardiac Assist Division · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 2011 · cites it directly2descendants
- 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 · 2 generations on0descendants
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) | K091449 | Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models… | Datascope Corp., Cardiac Assist Division | 2009 | — |
| +1 | K112327 | Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | 1 |
| +1 | K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and… | Datascope Corp. | 2013 | 9 |
| +2 | 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 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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.
Planning a device in DSP? 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? (4)
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…VICE INFORMATION Datascope's 8FrM 50cc LAB and Accessories are substantially equivalent to the following marketed devices: K041281 - Datascope's Linear 7.5Fr. LABs, S/E 6/7/04 K03 1569 - Datascope's CA40 8Fr. 1ABs, S/E 6/10/03 K01… | 2004 |
| * | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XXSummary page 1…sories are substantially equivalent to the following marketed devices: K041281 - Datascope's Linear 7.5Fr. LABs, S/E 6/7/04 K03 1569 - Datascope's CA40 8Fr. 1ABs, S/E 6/10/03 K013326 - Datascope's Fidelity 8Fr. JABs, S/E 11/02/01 K9… | 2003 |
| * | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Summary page 1…g marketed devices: K041281 - Datascope's Linear 7.5Fr. LABs, S/E 6/7/04 K03 1569 - Datascope's CA40 8Fr. 1ABs, S/E 6/10/03 K013326 - Datascope's Fidelity 8Fr. JABs, S/E 11/02/01 K903930 - Datascope's Percor Stat DL 10.5Ft. 50cc LABs, S/E 3/17/97… | 2001 |
| * | K903930 | Datascope Percor Stat DL 10.5 FR 50CCSummary page 1…. LABs, S/E 6/7/04 K03 1569 - Datascope's CA40 8Fr. 1ABs, S/E 6/10/03 K013326 - Datascope's Fidelity 8Fr. JABs, S/E 11/02/01 K903930 - Datascope's Percor Stat DL 10.5Ft. 50cc LABs, S/E 3/17/97… | 1990 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 46 ancestors have a recall of any class.
- Of its descendants, K112327 (Cardiac Assist, Maquet Cardiovascular, LLC, 2011) has gone furthest, with 2 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. 2009, 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?
Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have 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…
Read the full statement (95 words)
Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have 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/K091449 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091449
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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