510(k) · Cleared
ClearedViewFlex™ Eco Reprocessed ICE Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Jun 30, 2023 as substantially equivalent to K230934 (Abbott Medical, 2023) after a 29-day review. Its family tree reaches back 5 generations to 2010. 3 later devices descend from it.
- Decided
- Jun 30, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K101239 (2010). 6 ancestors in all, the oldest K071234 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK101239 Viewflex Plus Ice CatheterSt Jude Medical · 2010
- 4 generations backK121381 Viewflex Xtra Ice CatheterSt Jude Medical · 2012
- 3 generations backK133853 Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company · 2014
- 2 generations backK222217 ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical · 2022
- 1 generation backK230934 ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023
- This deviceK231588 ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical · 2023
- Descendant · cites it directly · 2 of its ownK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
- Descendant · 2 generations on · 0 of its ownK250305 Reprocessed Agilis NxT Steerable IntroducerInnovative Health · 2026
- Descendant · 2 generations on · 0 of its ownK250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical · 2025 · cites it directly2descendants
- K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health · 2026 · 2 generations on0descendants
- K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K101239 | Viewflex Plus Ice Catheter | St Jude Medical | 2010 | — |
| −4 | K121381 | Viewflex Xtra Ice Catheter | St Jude Medical | 2012 | — |
| −3 | K133853 | Viewflex Xtra Ice Catheter | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014 | — |
| −2 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter | Abbott Medical | 2022 | — |
| −1 | K230934 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | 2023 | — |
| 0 (this device) | K231588 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | 2023 | — |
| +1 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™… | Abbott Medical | 2025 | — |
| +2 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026 | — |
| +2 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025 | — |
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 |
|---|---|---|
| 2025 | 2 | 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.
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 |
|---|---|---|---|
| * | K230934 | ViewFlex™ Eco Reprocessed ICE CatheterSummary page 5…ascular Catheter Product Code OWQ Subsequent Product Code OBJ Predicate Device ViewFlex™ Eco Reprocessed ICE Catheter (K230934) Device Description The ViewFlex™ Eco Reprocessed ICE Catheter is a temporary… | 2023 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid… | 2025 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K251211 (Abbott Medical, 2025) has gone furthest, with 2 descendants of its own.
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 ViewFlex™ Eco Reprocessed 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/K231588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231588: ViewFlex™ Eco Reprocessed 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/K231588
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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