510(k) · Cleared
Recalled · 2009Intra-Aortic Balloon (Iab)
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 6, 2004 as substantially equivalent to K970689 (Arrow Intl., Inc., 1998) and 4 other predicates after a 38-day review. Its family tree reaches back 3 generations to 1989. 9 of the 18 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 13 times.
- Decided
- May 6, 2004
- Review
- 38 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 13
- Predicates
- 5
Its longest line of descent runs back 3 generations to K892799 (1989). 8 ancestors in all. 9 later devices descend from it, 1 citing it directly. 9 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK892799 8 FR Percutan Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1989
- 2 generations backK963920 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,Arrow Intl., Inc. · 1997
- 1 generation backK021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor…Arrow Intl., Inc. · 2002 · Recalled (Class I)
- This deviceK040801 Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004
- Descendant · cites it directly · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK151254 CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK181122 CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · Recalled (Class I)
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
2007high 2 (2011) · 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…direct predicate · 2000
- K993966 8FR. Narrowflex Universal Intra-Aortic Balloon…direct predicate · 2000
- K981660 Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic…2 generations back · 1998
Most influential descendants
Showing 5 of 9 · See all- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · cites it directly8descendants
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on3descendants
- K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on2descendants
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 3 generations on1descendant
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K892799 | 8 FR Percutan Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1989 | — |
| −2 | K963920 | 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter, | Arrow Intl., Inc. | 1997 | — |
| −1 | K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a… | Arrow Intl., Inc. | 2002 | Class I |
| 0 (this device) | K040801 | Intra-Aortic Balloon (Iab) | Arrow Intl., Inc. | 2004 | — |
| +1 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| +2 | K112372 | Cardiosave Hybrid Intra-Aortic Balloon Pump | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | Class I |
| +2 | K112327 | Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | 1 |
| +3 | K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | 2015 | Class I |
| +3 | K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | 2018 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 1 |
| 2000 | 2 | 2 |
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 | 2 | 1 |
| 2018 | 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.
9 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? (5)
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 |
|---|---|---|---|
| * | K970689 | Iab-04840-U;Iab-04250-U;Iab-04240-U;Iab-04230-USummary page 4…s substantial equivalence. Table 1: Predicate Devices K040801 Teleflex: Arrow International, Inc vavaw teieflex com 510(k) Intra-Aortic Balloon Description Catalog K970689 | IAB 8Fr, 30/40cc and, 10 Fr, 50cc with Peel-Away Hemostasis IAB-042XX- U K963920 | |AB 8Fr, 30cc Arrow NarrowFlex Universal IAB… | 1998 |
| * | K963920 | 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,Summary page 4…nternational, Inc vavaw teieflex com 510(k) Intra-Aortic Balloon Description Catalog K970689 | IAB 8Fr, 30/40cc and, 10 Fr, 50cc with Peel-Away Hemostasis IAB-042XX- U K963920 | |AB 8Fr, 30cc Arrow NarrowFlex Universal IAB-04830-U K993966 | IAB 8Fr, 40cc Arrow NarrowFlex Universal IAB-04840-U K000729 | |… | 1997 |
| * | K993966 | 8FR. Narrowflex Universal Intra-Aortic Balloon CatheterSummary page 4…oon Description Catalog K970689 | IAB 8Fr, 30/40cc and, 10 Fr, 50cc with Peel-Away Hemostasis IAB-042XX- U K963920 | |AB 8Fr, 30cc Arrow NarrowFlex Universal IAB-04830-U K993966 | IAB 8Fr, 40cc Arrow NarrowFlex Universal IAB-04840-U K000729 | |AB 8Fr, 30/40cc Arrow Ultra Series IAB-058XX-U / IAB-68XX-U K0… | 2000 |
| * | K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalSummary page 4…50cc with Peel-Away Hemostasis IAB-042XX- U K963920 | |AB 8Fr, 30cc Arrow NarrowFlex Universal IAB-04830-U K993966 | IAB 8Fr, 40cc Arrow NarrowFlex Universal IAB-04840-U K000729 | |AB 8Fr, 30/40cc Arrow Ultra Series IAB-058XX-U / IAB-68XX-U K021462 | |AB 8Fr, 30/40cc Arrow Ultra Series with Light Wave Sen… | 2000 |
| * | K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…Summary page 4…w NarrowFlex Universal IAB-04830-U K993966 | IAB 8Fr, 40cc Arrow NarrowFlex Universal IAB-04840-U K000729 | |AB 8Fr, 30/40cc Arrow Ultra Series IAB-058XX-U / IAB-68XX-U K021462 | |AB 8Fr, 30/40cc Arrow Ultra Series with Light Wave Sensor IAB-058XX-LWS E. Description of Device IAB's are designed to provi… | 2002 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… Class I | 2007 | 8 |
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2009 | Not classified | Z-1216-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1214-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1219-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1221-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1218-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1210-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1215-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1220-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1217-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1211-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1212-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1222-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
| Feb 2, 2009 | Not classified | Z-1213-2009 | Process design | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. |
The 5 latest of 13 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 · ◆ on the line of descent in FIG. 12 Class I recalls
- K000729Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · Direct predicate · ◆ 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
- 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
- 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 9; 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 5.0 years on median.
- 4 of the 8 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.
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 Intra-Aortic Balloon (IAB) 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/K040801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040801: Intra-Aortic Balloon (Iab).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040801
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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