510(k) · Cleared
ClearedSoundstar Eco Diagnostic Ultrasound Catheter
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 Nov 18, 2011 as substantially equivalent to K070242 (Biosense Webster, Inc., 2007) and 1 other predicate after a 123-day review. Its family tree reaches back 5 generations to 1992. 1 of the 14 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 123 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921148 (1992). 8 ancestors in all. 5 later devices descend from it, 3 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- 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 backK092064 Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc. · 2009
- This deviceK112050 Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK240050 SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK223766 NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK254149 Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use…Sterilmed, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250545 Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco…Surgical Instrument Service and Savings, Inc. · 2025 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK241540 NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2024
Class I recalls in this family
- K250545 Medline ReNewal Reprocessed Biosense Webster…cites it directly · 2025
Most influential descendants
Showing 5 of 5 · See all- K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc. · 2024 · cites it directly1descendant
- K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2023 · cites it directly1descendant
- K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc. · 2026 · 2 generations on0descendants
- K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc. · 2025 · cites it directly0descendants
- K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2024 · 2 generations on0descendants
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 | K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12 | Biosense Webster, Inc. | 2009 | — |
| 0 (this device) | K112050 | Soundstar Eco Diagnostic Ultrasound Catheter | Biosense Webster, Inc. | 2011 | — |
| +1 | K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | 2024 | — |
| +1 | K223766 | NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2023 | — |
| +2 | K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens… | Sterilmed, Inc. | 2026 | — |
| +1 | K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic… | Surgical Instrument Service and Savings, Inc. | 2025 | Class I |
| +2 | K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2024 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 1…SOUNDSTAR ecolOFG Catheters are substantially equivalent to the Biosense Webster SOUNDSTAR 3D Ultrasound Catheter (SNDSTR10) cleared on May 15, 2007 via 510(k) K070242 and also SOUNDSTAR 3D Ultrasound Catheter (SNDSTR10G) cleared on August 7, 2009 via 510(k) K092064 respectively.… | 2007 |
| * | K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12Summary page 1…sound Catheter (SNDSTR10) cleared on May 15, 2007 via 510(k) K070242 and also SOUNDSTAR 3D Ultrasound Catheter (SNDSTR10G) cleared on August 7, 2009 via 510(k) K092064 respectively. 43 of 82 DESCRIPTION OF MODIFIED DEVICE The modifie… | 2009 |
What descends from it? (5)
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 · Cites it directly · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K240050 (Biosense Webster, Inc., 2024) has gone furthest, with 1 descendant 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. 2011, 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® eco 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® 3 EP Navigation Systems, the SOUNDSTAR® eco Catheter provides location information. Please refer to the Compatibility Matrix Insert for Compatible CARTO® 3 Systems as each catheter is compatible with a specific version of CARTO® 3 and is not backwards compatible with previous versions of CARTO® 3 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/K112050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112050: Soundstar Eco 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/K112050
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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