510(k) · Cleared
ClearedReprocessed SoundStar 3D Diagnostic Ultrasound Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Jun 16, 2017 as substantially equivalent to K101138 (Biosense Webster, Inc., 2010) and 1 other predicate after a 120-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jun 16, 2017
- Review
- 120 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- 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.
- 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 backK101138 Soundstar 3D Ultrasound Catheter Model M-5723-12Biosense Webster, Inc. · 2010
- This deviceK170474 Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC · 2017
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 | K101138 | Soundstar 3D Ultrasound Catheter Model M-5723-12 | Biosense Webster, Inc. | 2010 | — |
| 0 (this device) | K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K101138 | Soundstar 3D Ultrasound Catheter Model M-5723-12Summary page 5…: OWQ Predicate Device: 510(k) Number 510(k) Title Manufacturer K101138 SoundStar 3D Diagnostic Ultrasound Biosense Webster, Inc.… | 2010 |
| * | K091352 | Soundstar 3D Diagnostic Catheter, Model M-5723-05Summary page 5…er K101138 SoundStar 3D Diagnostic Ultrasound Biosense Webster, Inc. Catheter K091352 SoundStar 3D Diagnostic Ultrasound Biosense Webster, Inc.… | 2009 |
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 25 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 SoundStar 3D Diagnostic Ultrasound Catheter is 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.
The SoundStar 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO EP Navigation Systems.
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/K170474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170474: Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170474
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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