510(k) · Cleared
ClearedArrow Acat 2 Intra-Aortic Balloon Pump
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 May 3, 2001 as substantially equivalent to K983866 (Belmont Instrument Corp., 2000) and 5 other predicates after a 282-day review. Its family tree reaches back 2 generations to 1991. 8 of the 24 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- May 3, 2001
- Review
- 282 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K905313 (1991). 6 ancestors in all. 17 later devices descend from it, 3 citing it directly. 8 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK905313 Kontron Intra-Aortic Balloon Pump, Model Kaat IIKontron Instruments, Inc. · 1991
- 1 generation backK965209 Acat 1 (Arrow Cardiac Assist Technology 1)Arrow Intl., Inc. · 1998 · Recalled
- This deviceK002256 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
- Descendant · 3 generations on · 3 of its ownK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- 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
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat II | Kontron Instruments, Inc. | 1991 | — |
| −1 | K965209 | Acat 1 (Arrow Cardiac Assist Technology 1) | Arrow Intl., Inc. | 1998 | 1 |
| 0 (this device) | 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 | — |
| +3 | K112372 | Cardiosave Hybrid Intra-Aortic Balloon Pump | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K983866 | Belmont Model Ngpbp Intra-Aortic Balloon PumpSummary page 5…R 870.3535) D. Predicate Devices The ACAT 2 is substantially equivalent to the following devices: 1. Belmont Model NGPBP IABP, Belmont Instruments Corporation (K983866) 2. ACAT 1, Arrow International (K965209) 3. KAAT II Plus IABP, Arrow International (K905313) 4. System 95 and… | 2000 |
| * | K965209 | Acat 1 (Arrow Cardiac Assist Technology 1)Summary page 5…is substantially equivalent to the following devices: 1. Belmont Model NGPBP IABP, Belmont Instruments Corporation (K983866) 2. ACAT 1, Arrow International (K965209) 3. KAAT II Plus IABP, Arrow International (K905313) 4. System 95 and 97 IABP, Datascope Corporation (K942454, K96150… | 1998 |
| * | K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat IISummary page 5…1. Belmont Model NGPBP IABP, Belmont Instruments Corporation (K983866) 2. ACAT 1, Arrow International (K965209) 3. KAAT II Plus IABP, Arrow International (K905313) 4. System 95 and 97 IABP, Datascope Corporation (K942454, K961509) 5. Bard Transact System H8000, Belmont Instrument… | 1991 |
| * | K942454 | Datascope 95 and 97 Iab Pump ConsoleSummary page 5…(K983866) 2. ACAT 1, Arrow International (K965209) 3. KAAT II Plus IABP, Arrow International (K905313) 4. System 95 and 97 IABP, Datascope Corporation (K942454, K961509) 5. Bard Transact System H8000, Belmont Instruments Corporation (K915580)… | 1995 |
| * | K961509 | Intra-Aortic Balloon Pump System 97 ModifiedSummary page 5…2. ACAT 1, Arrow International (K965209) 3. KAAT II Plus IABP, Arrow International (K905313) 4. System 95 and 97 IABP, Datascope Corporation (K942454, K961509) 5. Bard Transact System H8000, Belmont Instruments Corporation (K915580)… | 1996 |
| * | K915580 | Belmont Model PBP Intra-Aortic Balloon PumpSummary page 5…ow International (K905313) 4. System 95 and 97 IABP, Datascope Corporation (K942454, K961509) 5. Bard Transact System H8000, Belmont Instruments Corporation (K915580) Page 1 of 2 E. De… | 1992 |
What descends from it? (17)
See all 173 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)
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.
- 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K060309 (Arrow Intl., Inc., 2006) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K983866.
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 ACAT 2 Intra-Aortic Balloon Pump is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
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/K002256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002256: Arrow Acat 2 Intra-Aortic Balloon Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002256
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026