510(k) · Cleared
ClearedReprocessed ViewFlex™ Xtra ICE Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Nov 14, 2019 as substantially equivalent to K133853 (Irvine Biomedical, Inc., A St. Jude Medical Company, 2014) after a 260-day review. Its family tree reaches back 3 generations to 2010.
- Decided
- Nov 14, 2019
- Review
- 260 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K101239 (2010). 4 ancestors in all, the oldest K071234 (2007). No later device cites it as a predicate yet.
- 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 deviceK190478 Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc. · 2019
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) | K190478 | Reprocessed ViewFlex™ Xtra ICE Catheter | Sterilmed, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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…agnostic Intravascular Catheter Device Classification: Class II Product Code OWQ Predicate Device: ViewFlex™ Xtra ICE Catheter (K133853) The Reprocessed ViewFlex™ Xtra ICE catheter is a temporary intra… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 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.
- 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/K190478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190478: Reprocessed 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/K190478
Report an extraction error
Are you the manufacturer?
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