510(k) · Cleared
Recalled · Class I · 2025Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings, Inc. · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Jun 5, 2025 as substantially equivalent to K140318 (Biosense Webster, 2014) and 1 other predicate after a 100-day review. Its family tree reaches back 6 generations to 1992. 1 of the 11 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jun 5, 2025
- Review
- 100 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921148 (1992). 10 ancestors in all. No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 5 generations backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- 4 generations backK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK070242 Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc. · 2007
- 2 generations backK092064 Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc. · 2009
- 1 generation backK112050 Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011
- This deviceK250545 Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco…Surgical Instrument Service and Savings, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −5 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| −4 | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −3 | K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05 | Biosense Webster, Inc. | 2007 | — |
| −2 | K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12 | Biosense Webster, Inc. | 2009 | — |
| −1 | K112050 | Soundstar Eco Diagnostic Ultrasound Catheter | Biosense Webster, Inc. | 2011 | — |
| 0 (this device) | K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic… | Surgical Instrument Service and Savings, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K140318 | Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound CatheterSummary page 6…Class 2 Product Code OWQ Panel Cardiovascular The predicate models in K140318 include the 8FG and Predicate 8F subject device models of this submission. The selec… | 2014 |
| * | K112050 | Soundstar Eco Diagnostic Ultrasound CatheterSummary page 6…510(k) applicant 3333 Diamond Canyon Rd., Baldwin Bar, CA 91765 The predicate models in K112050 include the 10FG and Predicate 10F subject device models of this submission. The se… | 2011 |
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-1324-2026 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K140318.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F
10FG are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as
well as visualization of other devices in the heart. When used with compatible CARTO 3 EP Navigation Systems, the
SOUNDSTAR eco Catheter provides location information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250545: Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250545
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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