510(k) · Cleared
ClearedViewflex Plus Ice Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQO Catheter, Intravascular, Diagnostic
Cleared on Jun 2, 2010 after a 30-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 17 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- Jun 2, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
16 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.
- This deviceK101239 Viewflex Plus Ice CatheterSt Jude Medical · 2010
- Descendant · cites it directly · 15 of its ownK121381 Viewflex Xtra Ice CatheterSt Jude Medical · 2012
- Descendant · 2 generations on · 14 of its ownK133853 Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014
- Descendant · 3 generations on · 5 of its ownK222217 ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical · 2022
- Descendant · 4 generations on · 4 of its ownK230934 ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023
- Descendant · 3 generations on · 4 of its ownK223077 ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K232130 Medline ReNewal Reprocessed ViewFlex Xtra ICE…3 generations on · 2023
Most influential descendants
Showing 5 of 16 · See all- K121381Viewflex Xtra Ice CatheterSt Jude Medical · 2012 · cites it directly15descendants
- K133853Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014 · 2 generations on14descendants
- K222217ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical · 2022 · 3 generations on5descendants
- K230934ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023 · 4 generations on4descendants
- K223077ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company · 2022 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101239 | Viewflex Plus Ice Catheter | St Jude Medical | 2010 | — |
| +1 | K121381 | Viewflex Xtra Ice Catheter | St Jude Medical | 2012 | — |
| +2 | K133853 | Viewflex Xtra Ice Catheter | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014 | — |
| +3 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter | Abbott Medical | 2022 | — |
| +4 | K230934 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | 2023 | — |
| +3 | K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K073709 | FDA’s K073709 is Modification to Viewmate System Our reading of the summary gave K073709, FDA’s number for Modification to Viewmate System (Ep Medsystems). Its FDA name has none of the distinctive words the summary uses for the device it names, “ViewFlex Plus ICE Catheter”. Kept off the family tree. Summary page 1…asonic 892.1560, System, Imaging, Pulsed Echo, Ultrasonic 892.1200, Diagnostic Intravascular Catheter 2.4 Predicate Device K073709 ViewFlex Plus ICE Catheter (St. Jude Medical) 2.5 Indications for Use The ViewFlex Plus ICE Catheter, part of the ViewMate Sy… | 2008 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121381 | Viewflex Xtra Ice Catheter | 2012 | 15 |
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 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K121381 (St Jude Medical, 2012) has gone furthest, with 15 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The ViewFleXTM plus ICE Catheter, part of the ViewMate TM 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/K101239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101239: Viewflex Plus 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/K101239
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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