510(k) · Cleared
ClearedViewFlex Xtra ICE Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Biomedical, A St. Jude Medical Company · OBJ Catheter, Ultrasound, Intravascular
Cleared on Dec 7, 2022 as substantially equivalent to K133853 (Irvine Biomedical, Inc., A St. Jude Medical Company, 2014) after a 68-day review. Its family tree reaches back 3 generations to 2010. 4 later devices descend from it.
- Decided
- Dec 7, 2022
- Review
- 68 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K101239 (2010). 4 ancestors in all, the oldest K071234 (2007). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK101239 Viewflex Plus Ice CatheterSt Jude Medical · 2010
- 2 generations backK121381 Viewflex Xtra Ice CatheterSt Jude Medical · 2012
- 1 generation backK133853 Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014
- This deviceK223077 ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022
- Descendant · cites it directly · 2 of its ownK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
- Descendant · 2 generations on · 0 of its ownK250305 Reprocessed Agilis NxT Steerable IntroducerInnovative Health · 2026
- Descendant · 2 generations on · 0 of its ownK250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251231 ViewFlex™ X ICE Catheter, Sensor Enabled™Abbott Medical · 2025
Most influential descendants
Showing 4 of 4 · See all- K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical · 2025 · cites it directly2descendants
- K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health · 2026 · 2 generations on0descendants
- K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025 · 2 generations on0descendants
- K251231ViewFlex™ X ICE Catheter, Sensor Enabled™Abbott Medical · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K101239 | Viewflex Plus Ice Catheter | St Jude Medical | 2010 | — |
| −2 | K121381 | Viewflex Xtra Ice Catheter | St Jude Medical | 2012 | — |
| −1 | K133853 | Viewflex Xtra Ice Catheter | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014 | — |
| 0 (this device) | K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | 2022 | — |
| +1 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™… | Abbott Medical | 2025 | — |
| +2 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026 | — |
| +2 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K133853 | Viewflex Xtra Ice CatheterSummary page 4…ntravascular Catheter Product Code OBJ Subsequent Product Code OBJ Predicate Device ViewFlex™ Xtra ICE Catheter (K133853) Reference Device Not Applicable Device Description The ViewFlex™ Xtra ICE Catheter ("ViewF… | 2014 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K251211 (Abbott Medical, 2025) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K133853.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223077: ViewFlex Xtra ICE Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223077
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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