510(k) · Cleared
Recalled · Class I · 2022Autocat Intra-Aortic Balloon Pump Series
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 Apr 6, 2006 as substantially equivalent to K983866 (Belmont Instrument Corp., 2000) and 3 other predicates after a 58-day review. Its family tree reaches back 3 generations to 1991. 12 of the 29 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 29 times, including 28 Class I recalls.
- Decided
- Apr 6, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 29 (28 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K905313 (1991). 14 ancestors in all, the oldest K892799 (1989). 14 later devices descend from it, 3 citing it directly. 12 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK905313 Kontron Intra-Aortic Balloon Pump, Model Kaat IIKontron Instruments, Inc. · 1991
- 2 generations backK965209 Acat 1 (Arrow Cardiac Assist Technology 1)Arrow Intl., Inc. · 1998 · Recalled
- 1 generation backK002256 Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc. · 2001
- This deviceK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006
- Descendant · cites it directly · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK162820 AC3 Series IABP SystemArrow International, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK192238 AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019
- Descendant · 2 generations on · 3 of its ownK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK201112 AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · Recalled (Class I)
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
2007high 3 (2017) · low 0 (2008)2026
Class I recalls in this family
- K021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a…direct predicate · 2002
- K000729 Arrow Ultra 8 Intra-Aortic Balloon Catheters…2 generations back · 2000
- K993966 8FR. Narrowflex Universal Intra-Aortic Balloon…2 generations back · 2000
- K981660 Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic…2 generations back · 1998
Most influential descendants
Showing 5 of 14 · See all- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · cites it directly8descendants
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · cites it directly4descendants
- K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019 · 2 generations on3descendants
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on3descendants
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat II | Kontron Instruments, Inc. | 1991 | — |
| −2 | K965209 | Acat 1 (Arrow Cardiac Assist Technology 1) | Arrow Intl., Inc. | 1998 | 1 |
| −1 | K002256 | Arrow Acat 2 Intra-Aortic Balloon Pump | Arrow Intl., Inc. | 2001 | — |
| 0 (this device) | K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | 2006 | — |
| +1 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| +1 | K162820 | AC3 Series IABP System | Arrow International, Inc. | 2017 | Class I |
| +2 | K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex | 2019 | — |
| +2 | K112372 | Cardiosave Hybrid Intra-Aortic Balloon Pump | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | Class I |
| +1 | K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | Arrow International, Inc. | 2020 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 1 |
| 2000 | 3 | 2 |
| 2002 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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.
12 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? (4)
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…y equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: • AutoCAT, cleared in K983866, (1/6/00) • ACAT 1, cleared in K965209, (1/23/98) • ACAT 2, cleared in K002256, (5/3/01) • FOS I FOMS lAB Black… | 2000 |
| * | K965209 | Acat 1 (Arrow Cardiac Assist Technology 1)Summary page 5…Scientific Technology to the following legally marketed device in commercial distribution: • AutoCAT, cleared in K983866, (1/6/00) • ACAT 1, cleared in K965209, (1/23/98) • ACAT 2, cleared in K002256, (5/3/01) • FOS I FOMS lAB Black Box, cleared in K021462, (6/6/02) E. Desc… | 1998 |
| * | K002256 | Arrow Acat 2 Intra-Aortic Balloon PumpSummary page 5…egally marketed device in commercial distribution: • AutoCAT, cleared in K983866, (1/6/00) • ACAT 1, cleared in K965209, (1/23/98) • ACAT 2, cleared in K002256, (5/3/01) • FOS I FOMS lAB Black Box, cleared in K021462, (6/6/02) E. Description of Device The Intra-Aortic Ballo… | 2001 |
| * | K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…Summary page 5…CAT, cleared in K983866, (1/6/00) • ACAT 1, cleared in K965209, (1/23/98) • ACAT 2, cleared in K002256, (5/3/01) • FOS I FOMS lAB Black Box, cleared in K021462, (6/6/02) E. Description of Device The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provid… | 2002 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2022 | Class I | Z-0446-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0450-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0453-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0426-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0430-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0431-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0445-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0447-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0454-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0455-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0432-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0448-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0427-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0428-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0451-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0429-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0452-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0444-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0449-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Class I | Z-0456-2023 | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| May 20, 2020 | Class I | Z-2415-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| May 20, 2020 | Class I | Z-2413-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| May 20, 2020 | Class I | Z-2408-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| May 20, 2020 | Class I | Z-2411-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| May 20, 2020 | Class I | Z-2412-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| May 20, 2020 | Class I | Z-2414-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| May 20, 2020 | Class I | Z-2410-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| May 20, 2020 | Class I | Z-2409-2020 | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of… |
| Nov 12, 2007 | Not classified | Z-0550-2008 | Material/Component Contamination | Leak may occur in the helium drive system for the IABP |
The 5 latest of 29 recalls; the web page lists all.
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.
- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- 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
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersC.R. Bard, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · Cites it directly · ◆ 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 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 3 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 14 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K063525 (Datascope Corp., 2007) has gone furthest, with 8 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
2007high 3 (2017) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DSP
140in 2019
2007high 140 (2019) · low 73 (2017)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSP
4in 2025
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
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
| 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 AutoCAT Intra-Aortic Balloon Pump Series 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/K060309 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060309: Autocat Intra-Aortic Balloon Pump Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060309
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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