510(k) · Cleared
Recalled · Class II · 2025Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insightra Medical, Inc. · DSP System, Balloon, Intra-Aortic And Control
Cleared on Jan 12, 2009 as substantially equivalent to K062582 (Abiomed, Inc., 2006) and 1 other predicate after a 115-day review. Its family tree reaches back 8 generations to 1990. 1 of the 48 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Jan 12, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K892222 (1990). 47 ancestors in all, the oldest K790775 (1979). No later device cites it as a predicate yet. 1 of the 48 devices in this family, counting this one, has 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 deviceK082746 Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30…Insightra Medical, Inc. · 2009
Class I recalls in this family
- K000729 Arrow Ultra 8 Intra-Aortic Balloon Catheters…2 generations back · 2000
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) | K082746 | Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | Insightra Medical, Inc. | 2009 | — |
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 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 1 |
| 2006 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K062582 | Supracor Balloon CatheterSummary page 1…kit Classification Name: Intra-aortic balloon and control system (21 CFR 870.3535) Product Code: 74 DSP c. Predicate Devices Abiomed SupraCor Balloon Catheter (K062582) Datascope 7.5Fr lAB Catheter and Accessories (K041281) d. Device Description The Insightra Ultra IABP Catheter Kit is a 7 Fren… | 2006 |
| * | K041281 | Datascope 7.5FR. Iab Catheter and AccessoriesSummary page 1…l system (21 CFR 870.3535) Product Code: 74 DSP c. Predicate Devices Abiomed SupraCor Balloon Catheter (K062582) Datascope 7.5Fr lAB Catheter and Accessories (K041281) d. Device Description The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2025 | Class II | Z-2298-2025 | No Marketing Application | Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training. |
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.
- 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
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.
- 6 of the 47 ancestors have a recall of any class; 1 has a Class I recall.
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?
The Ultra IABP is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory left ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic percutaneous revascularization and interventional…
Read the full statement (108 words)
The Ultra IABP is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory left ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic percutaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative 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, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082746: Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082746
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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