510(k) · Cleared
ClearedViewFlex™ X ICE Catheter, Sensor Enabled™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · OBJ Catheter, Ultrasound, Intravascular
Cleared on May 20, 2025 as substantially equivalent to K223077 (Irvine Biomedical, A St. Jude Medical Company, 2022) after a 28-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- May 20, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K101239 (2010). 5 ancestors in all, the oldest K071234 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK101239 Viewflex Plus Ice CatheterSt Jude Medical · 2010
- 3 generations backK121381 Viewflex Xtra Ice CatheterSt Jude Medical · 2012
- 2 generations backK133853 Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014
- 1 generation backK223077 ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022
- This deviceK251231 ViewFlex™ X ICE Catheter, Sensor Enabled™Abbott Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K101239 | Viewflex Plus Ice Catheter | St Jude Medical | 2010 | — |
| −3 | K121381 | Viewflex Xtra Ice Catheter | St Jude Medical | 2012 | — |
| −2 | K133853 | Viewflex Xtra Ice Catheter | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014 | — |
| −1 | K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | 2022 | — |
| 0 (this device) | K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ | Abbott Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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.
Planning a device in OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K223077 | ViewFlex Xtra ICE CatheterSummary page 5…Diagnostic intravascular catheter Product Code OBJ – Catheter, Ultrasound, Intravascular Predicate Device ViewFlex™ Xtra ICE Catheter (K223077, cleared 07-Dec-2022) Reference Device N/A Device Description The ViewFlex™ X ICE Catheter Sensor Ena… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K223077.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The ViewFlex ™ X ICE Catheter Sensor Enabled ™ is indicated for use in adult and adolescent pediatric patients for intra-cardiac and intra-luminal visualization of cardiac and great vessels anatomy and physiology, as well as visualization of other devices in the heart. When used with a compatible three-dimensional mapping system, the catheter provides location information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251231: ViewFlex™ X ICE Catheter, Sensor Enabled™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251231
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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