510(k) · Cleared
Recalled · Class I · 2025Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Services and Savings, Inc. · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Dec 15, 2023 as substantially equivalent to K133853 (Irvine Biomedical, Inc., A St. Jude Medical Company, 2014) after a 151-day review. Its family tree reaches back 3 generations to 2010. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Dec 15, 2023
- Review
- 151 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- 2 (2 Class I)
- 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. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- 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 deviceK232130 Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc. · 2023
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) | K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | 2023 | — |
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.
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 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 6…Product Code OWQ Panel Cardiovascular 510(k) Number K133853 Proprietary or Trade ViewFlex Xtra ICE Catheter… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2025 | Class I | Z-1323-2026 | Under Investigation by firm | These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may… |
| Jul 31, 2025 | Class I | Z-2613-2025 | Under Investigation by firm | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 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. 2023, 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 Medline ReNewal 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232130: Medline ReNewal 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/K232130
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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