510(k) · Cleared
ClearedSoundstar 3D Diagnostic Catheter, Model M-5723-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Dec 4, 2009 as substantially equivalent to K070242 (Biosense Webster, Inc., 2007) after a 211-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Dec 4, 2009
- Review
- 211 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921148 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 3 generations backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- 2 generations backK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 1 generation backK070242 Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc. · 2007
- This deviceK091352 Soundstar 3D Diagnostic Catheter, Model M-5723-05Biosense Webster, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK170474 Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −3 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| −2 | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −1 | K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05 | Biosense Webster, Inc. | 2007 | — |
| 0 (this device) | K091352 | Soundstar 3D Diagnostic Catheter, Model M-5723-05 | Biosense Webster, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05Summary page 1…Intravascular Ultrasound Catheter/OBJ 11.7 CLASSIFICATION Class II 11.8 PREDICATE DEVICE SOIJNDSTARm 3D Ultrasound Catheter (K070242) cleared on May 15, 2007. 11.9 DESCRIPTION OF DEVICE The Biosense Webster SOUNDSTAR" 3D Ultr… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | 2017 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K170474 (Innovative Health, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K070242.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The Biosense Webster SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter and related accessory devices 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® EP Navigation Systems, the SOUNDSTAR™ 3D Catheter provides location information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091352: Soundstar 3D Diagnostic Catheter, Model M-5723-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091352
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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