510(k) · Cleared
ClearedSoundstar 3D Ultrasound Catheter, Model M-5723-12
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 Aug 7, 2009 as substantially equivalent to K070242 (Biosense Webster, Inc., 2007) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1992. 1 of the 17 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Aug 7, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K921148 (1992). 7 ancestors in all. 9 later devices descend from it, 3 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- 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 deviceK092064 Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK112050 Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK240050 SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK223766 NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK101138 Soundstar 3D Ultrasound Catheter Model M-5723-12Biosense Webster, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK254149 Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use…Sterilmed, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250545 Medline ReNewal Reprocessed Biosense Webster…2 generations on · 2025
Most influential descendants
Showing 5 of 9 · See all- K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011 · cites it directly5descendants
- K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc. · 2024 · 2 generations on1descendant
- K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2023 · 2 generations on1descendant
- K101138Soundstar 3D Ultrasound Catheter Model M-5723-12Biosense Webster, Inc. · 2010 · cites it directly1descendant
- K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc. · 2026 · 3 generations on0descendants
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) | K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12 | Biosense Webster, Inc. | 2009 | — |
| +1 | K112050 | Soundstar Eco Diagnostic Ultrasound Catheter | Biosense Webster, Inc. | 2011 | — |
| +2 | K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | 2024 | — |
| +2 | K223766 | NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2023 | — |
| +1 | K101138 | Soundstar 3D Ultrasound Catheter Model M-5723-12 | Biosense Webster, Inc. | 2010 | — |
| +3 | K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens… | Sterilmed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 1 |
| 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.
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 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? (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 |
|---|---|---|---|
| * | K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05Summary page 2…The modified SOUNDSTAR 3D Ultrasound Catheter is substantially equivalent to the SOUNDSTAR 3D Ultrasound Catheter (510(k) K070242) cleared on May 15, 2007, and also to the ACUSON ACUNAV 1OF Diagnostic Ultr… | 2007 |
| * | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10FSummary page 2…(510(k) K070242) cleared on May 15, 2007, and also to the ACUSON ACUNAV 1OF Diagnostic Ultrasound Catheter (5 10(k) K071234) cleared on June 29, 2007. 15.9 DESCRIPTION OF MODIFIED DEVICE The modifi… | 2007 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc. · 2025 · 2 generations on · ◆ in the 2025 descendants bar of FIG. 11 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.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K112050 (Biosense Webster, Inc., 2011) has gone furthest, with 5 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 the CARTO XP EP Navigation System, Version 9.7 or greater, the SOUNDSTAR 3D Catheter provides location information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092064: Soundstar 3D Ultrasound Catheter, Model M-5723-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092064
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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