510(k) · Cleared
ClearedAC3™ Range™ Intra-Aortic Balloon Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, LLC · DSP System, Balloon, Intra-Aortic And Control
Cleared on Mar 26, 2025 as substantially equivalent to K232343 (Arrow International, LLC, 2023) after a 30-day review. Its family tree reaches back 8 generations to 1991. 7 of the 20 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 26, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K905313 (1991). 19 ancestors in all, the oldest K892799 (1989). No later device cites it as a predicate yet. 7 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK905313 Kontron Intra-Aortic Balloon Pump, Model Kaat IIKontron Instruments, Inc. · 1991
- 7 generations backK965209 Acat 1 (Arrow Cardiac Assist Technology 1)Arrow Intl., Inc. · 1998 · Recalled
- 6 generations backK002256 Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc. · 2001
- 5 generations backK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Recalled (Class I)
- 4 generations backK162820 AC3 Series IABP SystemArrow International, Inc. · 2017 · Recalled (Class I)
- 3 generations backK192238 AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019
- 2 generations backK201112 AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · Recalled (Class I)
- 1 generation backK232343 AC3™ Series IABPArrow International, LLC · 2023
- This deviceK250542 AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat II | Kontron Instruments, Inc. | 1991 | — |
| −7 | K965209 | Acat 1 (Arrow Cardiac Assist Technology 1) | Arrow Intl., Inc. | 1998 | 1 |
| −6 | K002256 | Arrow Acat 2 Intra-Aortic Balloon Pump | Arrow Intl., Inc. | 2001 | — |
| −5 | K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | 2006 | Class I |
| −4 | K162820 | AC3 Series IABP System | Arrow International, Inc. | 2017 | Class I |
| −3 | K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex | 2019 | — |
| −2 | K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | Arrow International, Inc. | 2020 | Class I |
| −1 | K232343 | AC3™ Series IABP | Arrow International, LLC | 2023 | — |
| 0 (this device) | K250542 | AC3™ Range™ Intra-Aortic Balloon Pump | Arrow International, LLC | 2025 | — |
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 |
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.
7 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 K232343 AC3™ Series IABPscore 10.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K232343 | AC3™ Series IABPSummary page 5…System Product Code DSP Classification Class II Regulation 21 C.F.R. §870.3535 Panel Cardiovascular Predicate Device K232343 - AC3™ Series IAB Pump (cleared 30 August 2023) Device Description The AC3 Range IABP system is a profess… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 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.
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · 2 generations back · ◆ on the line of descent in FIG. 111 Class I recalls
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 3 generations back · ◆ on the line of descent in FIG. 128 Class I recalls
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · 4 generations back · ◆ 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 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 5 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 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 8 of the 19 ancestors have a recall of any class; 7 have a Class I recall.
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. 2025, this device’s year, is highlighted.
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 AC3Tm Range Intra-Aortic Balloon Pump is clinically indicated for use for the following
conditions:
1. Acute Coronary Syndrome
2. Cardiac and Non-Cardiac Surgery
3. Complications of Heart Failure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250542: AC3™ Range™ 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/K250542
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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