510(k) Report

510(k) · Cleared

Cleared

Supracor Intr-Aortic Balloon Pump Console

K070225510(k) TraditionalCleared Dec 13, 2007323-day reviewClass II21 CFR 870.3535

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abiomed, Inc. · DSP System, Balloon, Intra-Aortic And Control

Cleared on Dec 13, 2007 as substantially equivalent to K031636 (Datascope Corp., 2003) and 1 other predicate after a 323-day review. Its family tree reaches back 3 generations to 1991. 2 of the 10 devices in its family, counting itself, have a Class I recall.

Decided
Dec 13, 2007
Review
323 days
Class
Class II
Product code
DSP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K905313 (1991). 9 ancestors in all. No later device cites it as a predicate yet. 2 of the 10 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2003: 1 other ancestor, 1 with a Class I recall12000: 1 other ancestor1997: 1 other ancestor, 1 with a Class I recall11996: 1 other ancestor1995: 1 other ancestor1992: 1 other ancestorK905313 · Kontron Intra-Aortic Balloon Pump, Model Kaat II · Kontron Instruments, Inc. · 1991K965209 · Acat 1 (Arrow Cardiac Assist Technology 1) · Arrow Intl., Inc. · 1998 · recalledK002256 · Arrow Acat 2 Intra-Aortic Balloon Pump · Arrow Intl., Inc. · 20011990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor, 1 with a Class I recall12 generations back: 5 other ancestors, 1 with a Class I recall1 K002256 · Arrow Acat 2 Intra-Aortic Balloon Pump · Arrow Intl., Inc. · 2001K965209 · Acat 1 (Arrow Cardiac Assist Technology 1) · Arrow Intl., Inc. · 1998 · recalledK905313 · Kontron Intra-Aortic Balloon Pump, Model Kaat II · Kontron Instruments, Inc. · 19910
  1. Root · 3 generations backK905313 Kontron Intra-Aortic Balloon Pump, Model Kaat IIKontron Instruments, Inc. · 1991
  2. 2 generations backK965209 Acat 1 (Arrow Cardiac Assist Technology 1)Arrow Intl., Inc. · 1998 · Recalled
  3. 1 generation backK002256 Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc. · 2001
  4. This deviceK070225 Supracor Intr-Aortic Balloon Pump ConsoleAbiomed, Inc. · 2007

Class I recalls in this family

  • K031636 CS100 Intra-Aortic Balloon Pump, Model…direct predicate · 2003
  • K965236 System 96 Intra-Aortic Balloon Pump (Iabp)2 generations back · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K905313Kontron Intra-Aortic Balloon Pump, Model Kaat IIKontron Instruments, Inc.1991—
−2K965209Acat 1 (Arrow Cardiac Assist Technology 1)Arrow Intl., Inc.19981
−1K002256Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc.2001—
0 (this device)K070225Supracor Intr-Aortic Balloon Pump ConsoleAbiomed, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
199610
199711
200010
200311
FIG. 1 — Lineage of K070225, 1991–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

2 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. #1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX
Summary page 1
…(Class III under CFR870.3535) Product Code: 74DSP c. Legally Marketed Predicate Devices Datascope CS100 Intra-Aortic Balloon Pump (K031636) Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256) d. Device Description: The iPulse Intra-Aortic Balloon Pump (IABP) Console i…
Datascope Corp.2003Class I
*K002256Arrow Acat 2 Intra-Aortic Balloon Pump
Summary page 1
…roduct Code: 74DSP c. Legally Marketed Predicate Devices Datascope CS100 Intra-Aortic Balloon Pump (K031636) Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256) d. Device Description: The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's l…
Arrow Intl., Inc.2001—

Also cleared against K031636: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 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.

  • K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 15 Class I recalls
  • K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
  • 3 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
  • 2 other devices also cite its predicate K031636.

How does its category compare?

All DSP devices

DSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DSP

1in 2025

2007: 22009: 22011: 22012: 22013: 12015: 12017: 32018: 12019: 32020: 22023: 12025: 1
2007high 3 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSP

140in 2019

2017: 73 days median2019: 140 days median
2007high 140 (2019) · low 73 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSP

4in 2025

2007: 32009: 142010: 82012: 32014: 12016: 9, 9 Class I2018: 2, 2 Class I2019: 32021: 5, 3 Class I2022: 33, 33 Class I2024: 12025: 4
2007high 33 (2022) · low 0 (2008)2026

Class I (47 since 2007) Class II/III not classified

Adverse event reports per year · DSP

7,422in 2025

2007: 4612008: 6172009: 6562010: 1,0192011: 5902012: 4902013: 4952014: 1,7382015: 4042016: 4192017: 2,1642018: 3,3312019: 3,5522020: 3,3932021: 4,3452022: 5,1132023: 6,9802024: 7,3172025: 7,422
2007high 7,422 (2025) · low 404 (2015)2025

MAUDE reports naming product code DSP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—3461
20080—0617
20092—14656
20100—81,019
20112—0590
20122—3490
20131—0495
20140—11,738
20151—0404
20160—9 (9)419
201737302,164
20181—2 (2)3,331
2019314033,552
20202—03,393
20210—5 (3)4,345
20220—33 (33)5,113
20231—06,980
20240—17,317
20251—47,422
20260—0—

What is it indicated for?

The Pulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to…

Read the full statement (218 words)

The Pulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle.

Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:

* 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.

Also cleared against K031636

2 other devices cite the same predicate.

  • K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. · 20172 recalls
  • K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 20071 Class I recall

More from Abiomed, Inc.

209 FDA decisions under this applicant name. See the company

  • P140003/S138Impella CP with SmartAssistAbiomed, Inc. · 2026
  • P140003/S137Impella 5.5 with Smart AssistAbiomed, Inc. · 2026
  • P170011/S063Impella RP SystemAbiomed, Inc. · 2026
  • P140003/S135Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5…Abiomed, Inc. · 2026
  • P170011/S061Impella RP System, Impella RP with Smart Assist System, Impella RP Flex SystemAbiomed, Inc. · 2026

Recent decisions in DSP

The DSP category page

  • K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC · 2025
  • K232343AC3™ Series IABPArrow International, LLC · 2023
  • K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 202011 Class I recalls
  • K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 20201 Class I recall
  • K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019

https://510kreport.com/device/K070225 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070225: Supracor Intr-Aortic Balloon Pump Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070225

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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