510(k) · Cleared
Recalled · 2007Acat 1 (Arrow Cardiac Assist Technology 1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DSP System, Balloon, Intra-Aortic And Control
Cleared on Jan 23, 1998 as substantially equivalent to K905313 (Kontron Instruments, Inc., 1991) after a 392-day review. Its family tree reaches back 1 generation to 1991. 8 of the 20 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled once.
- Decided
- Jan 23, 1998
- Review
- 392 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905313 (1991). 18 later devices descend from it, 2 citing it directly. 8 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK905313 Kontron Intra-Aortic Balloon Pump, Model Kaat IIKontron Instruments, Inc. · 1991
- This deviceK965209 Acat 1 (Arrow Cardiac Assist Technology 1)Arrow Intl., Inc. · 1998
- Descendant · cites it directly · 17 of its ownK002256 Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc. · 2001
- Descendant · cites it directly · 14 of its ownK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK162820 AC3 Series IABP SystemArrow International, Inc. · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK192238 AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K002256Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc. · 2001 · cites it directly17descendants
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · cites it directly14descendants
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · 2 generations on8descendants
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 2 generations on4descendants
- K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat II | Kontron Instruments, Inc. | 1991 | — |
| 0 (this device) | K965209 | Acat 1 (Arrow Cardiac Assist Technology 1) | Arrow Intl., Inc. | 1998 | — |
| +1 | K002256 | Arrow Acat 2 Intra-Aortic Balloon Pump | Arrow Intl., Inc. | 2001 | — |
| +1 | K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | 2006 | Class I |
| +2 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| +2 | K162820 | AC3 Series IABP System | Arrow International, Inc. | 2017 | Class I |
| +3 | K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 2 | 1 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 3 | 2 |
| 2018 | 1 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 1 |
| 2023 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat IISummary page 1…the following legally marketed intra-aortic balloon pumps: 1. The KAAT II Plus IABP catalog no. IAP-00025, from Arrow International, Everett, MA, Premarket Notification K905313. 2. The System 95 & 97 IABP, from Datascope Corporation, Paramus, NJ. 3. The TransAct H-8000 IABP, from C. R. Bard, Inc. Haverh… | 1991 |
| * | — | System 95 & 97 IABP Named without a submission number | |
| * | — | TransAct H-8000 IABP Named without a submission number |
What descends from it? (18)
See all 182 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 |
|---|---|---|---|---|
| Nov 12, 2007 | Not classified | Z-0549-2008 | Material/Component Contamination | Leak may occur in the helium drive system for the IABP |
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.
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 128 Class I recalls
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 111 Class I recalls
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
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?
Cardiogenic shock Pre- shock syndrome Post- Infarction angina (Threatening extension of MI) Unstable refractory angina, or impending infraction Ischemia related intractable ventricular dysrhythmias Septic shock syndrome Cardiac contusion Support for diagnostic interventional procedures including: _Cardiac Angiography Coronary Angioplasty (PTCA) Coronary Atherectomy Failed Mitral Valvuloplasty Mechanical complications. due to-acute myocardial infraction:-…
Read the full statement (116 words)
Cardiogenic shock
Pre- shock syndrome
Post- Infarction angina (Threatening extension of MI)
Unstable refractory angina, or impending infraction
Ischemia related intractable ventricular dysrhythmias
Septic shock syndrome
Cardiac contusion
Support for diagnostic interventional procedures including:
_Cardiac Angiography
Coronary Angioplasty (PTCA)
Coronary Atherectomy
Failed Mitral Valvuloplasty
Mechanical complications. due to-acute myocardial infraction:- - -~
Valvular stenosis - Mitral stenosis
Mitral Valve insufficiency - Mitral regurgitation
Ventricular Septal Defect (VSD)
Papillary muscle rupture
Prophylactic support in preparation for cardiac surgery or high risk cardiac
patients undergoing non cardiac surgical procedures
Post-surgical myocardial dysfunction
Cardiac support following correction of anatomical defects
Maintenance of graft patency post coronary bypass surgery
Pulsatile flow during cardiopulmonary bypass
Mechanical bridge to other assist devices.
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/K965209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965209: Acat 1 (Arrow Cardiac Assist Technology 1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965209
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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