510(k) · Cleared
Recalled · Class II · 2020Reprocessed ViewFlex Xtra ICE Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on May 8, 2019 as substantially equivalent to K133853 (Irvine Biomedical, Inc., A St. Jude Medical Company, 2014) after a 261-day review. Its family tree reaches back 3 generations to 2010. 1 later device descends from it. It has been recalled once.
- Decided
- May 8, 2019
- Review
- 261 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K101239 (2010). 4 ancestors in all, the oldest K071234 (2007). 1 later device descends from it, 1 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 deviceK182238 Reprocessed ViewFlex Xtra ICE CatheterStryker Sustainability Solutions · 2019
- Descendant · cites it directly · 0 of its ownK231621 Reprocessed ViewFlex Xtra ICE Catheter (D087031)Stryker Sustainability Solutions · 2023
Most influential descendants
Showing 1 of 1 · See all- K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)Stryker Sustainability Solutions · 2023 · 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) | K182238 | Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions | 2019 | — |
| +1 | K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 OWQ? 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 OWQ device
- #1 K254149 Reprocessed AcuNav CRYSTAL™ Ultrasound…score 13.4 · 7 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 5…Irvine Biomedical D087031 K133853 VIEWFLEX XTRA ICE CATHETER Inc. A St. Jude… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2020 | Class II | Z-2113-2020 | Labeling False and Misleading | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 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, K231621 (Stryker Sustainability Solutions, 2023) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K133853.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OWQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWQ
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWQ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWQ
42in 2025
MAUDE reports naming product code OWQ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 3 | 261 | 0 | 9 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 38 |
| 2022 | 2 | — | 0 | 24 |
| 2023 | 8 | 78 | 0 | 29 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 3 | 100 | 2 | 42 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Reprocessed 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/K182238 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182238: Reprocessed ViewFlex Xtra ICE Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182238
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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