510(k) · Cleared
ClearedViewflex Xtra Ice Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 7, 2012 as substantially equivalent to K101239 (St Jude Medical, 2010) after a 30-day review. Its family tree reaches back 1 generation to 2010. 1 of the 17 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Jun 7, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101239 (2010). 15 later devices descend from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK101239 Viewflex Plus Ice CatheterSt Jude Medical · 2010
- This deviceK121381 Viewflex Xtra Ice CatheterSt Jude Medical · 2012
- Descendant · cites it directly · 14 of its ownK133853 Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014
- Descendant · 2 generations on · 5 of its ownK222217 ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical · 2022
- Descendant · 3 generations on · 4 of its ownK230934 ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023
- Descendant · 2 generations on · 4 of its ownK223077 ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022
- Descendant · 4 generations on · 3 of its ownK231588 ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K232130 Medline ReNewal Reprocessed ViewFlex Xtra ICE…2 generations on · 2023
Most influential descendants
Showing 5 of 15 · See all- K133853Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014 · cites it directly14descendants
- K222217ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical · 2022 · 2 generations on5descendants
- K230934ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023 · 3 generations on4descendants
- K223077ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022 · 2 generations on4descendants
- K231588ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101239 | Viewflex Plus Ice Catheter | St Jude Medical | 2010 | — |
| 0 (this device) | K121381 | Viewflex Xtra Ice Catheter | St Jude Medical | 2012 | — |
| +1 | K133853 | Viewflex Xtra Ice Catheter | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014 | — |
| +2 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter | Abbott Medical | 2022 | — |
| +3 | K230934 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | 2023 | — |
| +2 | K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | 2022 | — |
| +4 | K231588 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K101239 | Viewflex Plus Ice CatheterSummary page 1…Echo, Ultrasonic _______________________892.1200, Diagnostic Intravascular Catheter Predicate Device: ViewFlex Plus Catheter (K101 239) Device Description: The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular… | 2010 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133853 | Viewflex Xtra Ice Catheter | 2014 | 14 |
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 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K133853 (Irvine Biomedical, Inc., A St. Jude Medical Company, 2014) has gone furthest, with 14 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The ViewFlex Xtra ICE Catheter, part of the ViewMate System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121381: 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/K121381
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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