510(k) · Cleared
Recalled · Class I · 2024UltraFlex IAB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. · DSP System, Balloon, Intra-Aortic And Control
Cleared on Jun 28, 2019 as substantially equivalent to K993966 (Arrow Intl., Inc., 2000) after a 157-day review. Its family tree reaches back 1 generation to 2000. 2 of the 2 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jun 28, 2019
- Review
- 157 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993966 (2000). No later device cites it as a predicate yet. 2 of the 2 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK993966 8FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · Recalled (Class I)
- This deviceK190101 UltraFlex IABArrow International, Inc. · 2019
Class I recalls in this family
- K993966 8FR. Narrowflex Universal Intra-Aortic Balloon…direct predicate · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993966 | 8FR. Narrowflex Universal Intra-Aortic Balloon Catheter | Arrow Intl., Inc. | 2000 | Class I |
| 0 (this device) | K190101 | UltraFlex IAB | Arrow International, Inc. | 2019 | — |
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.
2 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? (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 |
|---|---|---|---|
| * | K993966 | 8FR. Narrowflex Universal Intra-Aortic Balloon CatheterSummary page 4…Name: Intra-aortic balloon and control system (21 CFR 870.3535). Regulatory Class II Legally • K993966 Arrow 8Fr. NarrowFlex® Universal Intra-Aortic Balloon Marketed Catheter (Arrow International, Inc.- Cle… | 2000 |
| † | K010330 | Arrow Rediguard, 9FR. 50CC, Intra-Aortic Balloon Vatheter, Iab-R950-U | 2001 |
| † | K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC Universal | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2024 | Class I | Z-1879-2024 | Nonconforming Material/Component | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely… |
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.
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- 2 other devices also cite its predicate K993966.
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. 2019, 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?
UltraFlex™ IAB with Intra-Aortic Balloon Pump as a control system is indicated for use in any of 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/K190101 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190101: UltraFlex IAB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190101
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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