510(k) · Cleared
ClearedSupracor Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · DSP System, Balloon, Intra-Aortic And Control
Cleared on Dec 14, 2006 as substantially equivalent to K980385 (Datascope Corp., 1998) and 1 other predicate after a 105-day review. Its family tree reaches back 4 generations to 1990. 1 of the 38 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 14, 2006
- Review
- 105 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K892222 (1990). 36 ancestors in all, the oldest K790775 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 3 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- 2 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
- 1 generation backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- This deviceK062582 Supracor Balloon CatheterAbiomed, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK082746 Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30…Insightra Medical, Inc. · 2009 · Recalled
Class I recalls in this family
- K000729 Arrow Ultra 8 Intra-Aortic Balloon Catheters…direct predicate · 2000
Most influential descendants
Showing 1 of 1 · See all- K082746Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −3 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| −2 | K972113 | 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel | Boston Scientific Corp | 1997 | — |
| −1 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| 0 (this device) | K062582 | Supracor Balloon Catheter | Abiomed, Inc. | 2006 | — |
| +1 | K082746 | Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | Insightra Medical, Inc. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Summary page 1…Intra-aortic Balloon (classified under CFR870.3535) Product Code: 74DSP c. Legally Marketed Predicate Devices Datascope Fidelity lAB catheter (K 980385), 8 F, 40 cc Intra-Aortic Balloon catheter Arrow Ultra 8 lAB catheter (K000729), 8 F, 40 cc Intra-Aortic Balloon catheter… | 1998 |
| * | K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalSummary page 1…74DSP c. Legally Marketed Predicate Devices Datascope Fidelity lAB catheter (K 980385), 8 F, 40 cc Intra-Aortic Balloon catheter Arrow Ultra 8 lAB catheter (K000729), 8 F, 40 cc Intra-Aortic Balloon catheter d. Device Description: The SupraCor Balloon Catheter is a 40cc symmetrical polyure… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082746 | Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this 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.
- K000729Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 36 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K082746 (Insightra Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K980385.
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.
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 intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations: * Unstable refractory angina * Impending infarction * Post Infarction Angina or Threatening Extension of Myocardial Infarction * Refractory ventricular failure * Mechanical complications because of myocardial infarction * Cardiogenic shock * Support and stabilization of high risk…
Read the full statement (136 words)
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations:
* Unstable refractory angina
* Impending infarction
* Post Infarction Angina or Threatening Extension of Myocardial Infarction
* Refractory ventricular failure
* Mechanical complications because of myocardial infarction
* Cardiogenic shock
* Support and stabilization of high risk patients undergoing diagnostic and non-surgical procedures
* Ischemic related intractable ventricular arrhythmias
* Septic shock
* Interoperative pulsatile flow generation
* Weaning from cardiopulmonary bypass
* Cardiac support for high risk surgical patients and coronary angiography and angioplasty patients
* Prophylactic support in preparation for cardiac surgery
Post-surgical myocardial dysfunction
Cardiac Contusion
* Mechanical bridge to other assist devices
* Cardiac support following correction of anatomical defects
* Support for failed angioplasty and valvuloplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062582: Supracor Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062582
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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