510(k) · Cleared
Recalled · Class I · 2016Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840
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 Jun 6, 2002 as substantially equivalent to K000729 (Arrow Intl., Inc., 2000) and 3 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1989. 13 of the 25 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 24 times, including 2 Class I recalls.
- Decided
- Jun 6, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 24 (2 Class I)
- Predicates
- 4
Its longest line of descent runs back 2 generations to K892799 (1989). 6 ancestors in all. 18 later devices descend from it, 5 citing it directly. 13 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK892799 8 FR Percutan Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1989
- 1 generation backK963920 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,Arrow Intl., Inc. · 1997
- This deviceK021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor…Arrow Intl., Inc. · 2002
- Descendant · cites it directly · 14 of its ownK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Recalled (Class I)
- Descendant · cites it directly · 9 of its ownK040801 Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · Recalled
- 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 · 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
2004high 3 (2017) · low 0 (2005)2026
Class I recalls in this family
- 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…direct predicate · 1998
- K200634 Arrow FiberOptix Intra-Aortic Balloon Catheter Kitcites it directly · 2020
Most influential descendants
Showing 5 of 18 · See all- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · cites it directly14descendants
- K040801Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · cites it directly9descendants
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · cites it directly8descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K892799 | 8 FR Percutan Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1989 | — |
| −1 | K963920 | 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter, | Arrow Intl., Inc. | 1997 | — |
| 0 (this device) | K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a… | Arrow Intl., Inc. | 2002 | — |
| +1 | K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | 2006 | Class I |
| +1 | K040801 | Intra-Aortic Balloon (Iab) | Arrow Intl., Inc. | 2004 | 13 |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 1 |
| 2000 | 2 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 1 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 3 | 2 |
| 2018 | 1 | 1 |
| 2019 | 2 | 0 |
| 2020 | 2 | 2 |
| 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.
13 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 |
|---|---|---|---|
| * | K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalSummary page 4…ra-Aortic Balloon (IAB) Catheter with A Fiber Optic Sensor Intra-Aortic Balloon (IAB) with a Fiber Optic Sensor and Measurement 510(k) Intra-Aortic Balloon Description K000729 IAB 8Fr, 30cc Arrow Ultra 8 K000729 |AB 8Fr, 40cc Arrow Ultre 8 K963920 IAB 8Fr, 30cc Arrow NarrowFlex Universal K993966 IAB 8Fr,… | 2000 |
| * | K963920 | 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,Summary page 4…Balloon (IAB) with a Fiber Optic Sensor and Measurement 510(k) Intra-Aortic Balloon Description K000729 IAB 8Fr, 30cc Arrow Ultra 8 K000729 |AB 8Fr, 40cc Arrow Ultre 8 K963920 IAB 8Fr, 30cc Arrow NarrowFlex Universal K993966 IAB 8Fr, 40cc Arrow NarrowFlex Universal K981660 IAB 8Fr, 40cc RediGuard Arrow A… | 1997 |
| * | K993966 | 8FR. Narrowflex Universal Intra-Aortic Balloon CatheterSummary page 4…urement 510(k) Intra-Aortic Balloon Description K000729 IAB 8Fr, 30cc Arrow Ultra 8 K000729 |AB 8Fr, 40cc Arrow Ultre 8 K963920 IAB 8Fr, 30cc Arrow NarrowFlex Universal K993966 IAB 8Fr, 40cc Arrow NarrowFlex Universal K981660 IAB 8Fr, 40cc RediGuard Arrow ArmorGlide The fiber optic sensor and measurement… | 2000 |
| * | K981660 | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersSummary page 4…K000729 IAB 8Fr, 30cc Arrow Ultra 8 K000729 |AB 8Fr, 40cc Arrow Ultre 8 K963920 IAB 8Fr, 30cc Arrow NarrowFlex Universal K993966 IAB 8Fr, 40cc Arrow NarrowFlex Universal K981660 IAB 8Fr, 40cc RediGuard Arrow ArmorGlide The fiber optic sensor and measurement system is technologically equivalent to the foll… | 1998 |
| † | K982702 | Ventrix Subdural Tunneling Pressure Monitoring Kit Model NL950-SD | 1998 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060309 | Autocat Intra-Aortic Balloon Pump Series Class I | 2006 | 14 |
| K040801 | Intra-Aortic Balloon (Iab) | 2004 | 9 |
| K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… Class I | 2007 | 8 |
| K190117 | Fiberoptix IAB | 2019 | 1 |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Class I | 2020 | 0 |
Has anything in its family been recalled? (13 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2016 | Class I | Z-1057-2016 | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. |
| Feb 10, 2016 | Class I | Z-1055-2016 | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. |
| Feb 5, 2015 | Class II | Z-1233-2015 | Labeling mix-ups | Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr |
| Nov 8, 2013 | Class II | Z-1259-2015 | Process control | Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere. |
| Nov 27, 2012 | Class II | Z-1064-2013 | Process control | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. |
| Nov 27, 2012 | Class II | Z-1065-2013 | Process control | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. |
| Oct 11, 2010 | Not classified | Z-0790-2011 | Device Design | SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. |
| Oct 11, 2010 | Not classified | Z-0791-2011 | Device Design | SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. |
| Oct 11, 2010 | Not classified | Z-0792-2011 | Device Design | SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. |
| Oct 11, 2010 | Not classified | Z-0793-2011 | Device Design | SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. |
| Oct 11, 2010 | Not classified | Z-0969-2011 | Device Design | SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. |
| 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 24 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.
- 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 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
- K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- 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
- 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
- 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 · 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 12; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 6 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K060309 (Arrow Intl., Inc., 2006) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K000729.
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 Arrow Intra-Aortic Balloon (IAB) Catheter With a Fiber Optic Sensor and a Measurement System 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/K021462 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021462
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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