510(k) · Cleared
ClearedSoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
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 21, 2016 as substantially equivalent to K140318 (Biosense Webster, 2014) and 1 other predicate after a 154-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Nov 21, 2016
- Review
- 154 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921148 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 4 generations backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- 3 generations backK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 2 generations backK070242 Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc. · 2007
- 1 generation backK110076 Reprocessed 3D Diagnostic Ultrasound CatheterSterilmed, Inc. · 2011 · Recalled
- This deviceK161700 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar…Sterilmed, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −4 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| −3 | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −2 | K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05 | Biosense Webster, Inc. | 2007 | — |
| −1 | K110076 | Reprocessed 3D Diagnostic Ultrasound Catheter | Sterilmed, Inc. | 2011 | 1 |
| 0 (this device) | K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D… | Sterilmed, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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.
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? (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 5…OWQ Predicate Biosense Webster, Inc.: SoundStar eco 8F G Ultrasound Catheter, and SoundStar Device: eco 8F Ultrasound Catheter (510(k) K140318) Secondary / Sterilmed Inc: Reprocessed 3D Ultrasound Diagnostic Catheter (510(k) K110076) Reference Sterilmed Inc:… | 2014 |
| * | K110076 | Reprocessed 3D Diagnostic Ultrasound CatheterSummary page 5…heter, and SoundStar Device: eco 8F Ultrasound Catheter (510(k) K140318) Secondary / Sterilmed Inc: Reprocessed 3D Ultrasound Diagnostic Catheter (510(k) K110076) Reference Sterilmed Inc: Reprocessed Ivus Imaging Catheter (510(k) K043453) Predicates Device Sterilmed Repro… | 2011 |
| † | K043453 | Sterilemed Reprocessed Ivus Imaging Catheter | 2005 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 8 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. 2016, 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 3D Diagnostic Ultrasound eco Catheters 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 (version 2.3 and higher) the reprocessed 3D Diagnostic Ultrasound eco Catheters provide location information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161700: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161700
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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