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, Inc., A St. Jude Medical Company · OBJ Catheter, Ultrasound, Intravascular
Cleared on May 19, 2014 as substantially equivalent to K121381 (St Jude Medical, 2012) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 2010. 1 of the 18 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- May 19, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K101239 (2010). 3 ancestors in all, the oldest K071234 (2007). 14 later devices descend from it, 8 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK101239 Viewflex Plus Ice CatheterSt Jude Medical · 2010
- 1 generation backK121381 Viewflex Xtra Ice CatheterSt Jude Medical · 2012
- This deviceK133853 Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014
- Descendant · cites it directly · 5 of its ownK222217 ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical · 2022
- Descendant · 2 generations on · 4 of its ownK230934 ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023
- Descendant · cites it directly · 4 of its ownK223077 ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022
- Descendant · 3 generations on · 3 of its ownK231588 ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023
- Descendant · 2 generations on · 2 of its ownK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K232130 Medline ReNewal Reprocessed ViewFlex Xtra ICE…cites it directly · 2023
Most influential descendants
Showing 5 of 14 · See all- K222217ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical · 2022 · cites it directly5descendants
- K230934ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023 · 2 generations on4descendants
- K223077ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022 · cites it directly4descendants
- K231588ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023 · 3 generations on3descendants
- K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical · 2025 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101239 | Viewflex Plus Ice Catheter | St Jude Medical | 2010 | — |
| −1 | K121381 | Viewflex Xtra Ice Catheter | St Jude Medical | 2012 | — |
| 0 (this device) | K133853 | Viewflex Xtra Ice Catheter | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014 | — |
| +1 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter | Abbott Medical | 2022 | — |
| +2 | K230934 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | 2023 | — |
| +1 | K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | 2022 | — |
| +3 | K231588 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | 2023 | — |
| +2 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™… | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 1 |
| 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.
1 device in this family has 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 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? (2)
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 |
|---|---|---|---|
| * | K121381 | Viewflex Xtra Ice CatheterSummary page 1…3. Predicate Device Information 1) ViewFlex Xtra ICE Catheter (Irvine Biomedical, Inc. a St. Jude Medical Company) - K121381 cleared June 7, 2012 2) AcuNav Diagnostic Ultrasound Catheter (Siemens Medical Solutions USA, Inc.)… | 2012 |
| * | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10FSummary page 1…Company) - K121381 cleared June 7, 2012 2) AcuNav Diagnostic Ultrasound Catheter (Siemens Medical Solutions USA, Inc.) -K071234 cleared June 29, 2007 Page 1 of 3 K133853 ViewFlex Xtra I… | 2007 |
What descends from it? (14)
See all 148 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222217 | ViewFlex Xtra Reprocessed ICE Catheter | 2022 | 5 |
| K223077 | ViewFlex Xtra ICE Catheter | 2022 | 4 |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | 2019 | 1 |
| K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | 2018 | 1 |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter Class I | 2023 | 0 |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | 2023 | 0 |
| K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | 2020 | 0 |
| K190478 | Reprocessed ViewFlex™ Xtra ICE Catheter | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K222217 (Abbott Medical, 2022) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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/K133853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133853: Viewflex Xtra Ice Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133853
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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