510(k) · Cleared
Recalled · Class II · 2015Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster · OBJ Catheter, Ultrasound, Intravascular
Cleared on Mar 12, 2014 after a 30-day review. The FDA summary names its predicate without a number. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 12, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK140318 Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound…Biosense Webster · 2014
- 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 · cites it directly · 0 of its ownK161700 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar…Sterilmed, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK142395 SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
Class I recalls in this family
- K250545 Medline ReNewal Reprocessed Biosense Webster…cites it directly · 2025
Most influential descendants
Showing 3 of 3 · See all- K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc. · 2025 · cites it directly0descendants
- K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…Sterilmed, Inc. · 2016 · cites it directly0descendants
- K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140318 | Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound Catheter | Biosense Webster | 2014 | — |
| +1 | K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic… | Surgical Instrument Service and Savings, Inc. | 2025 | Class I |
| +1 | K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D… | Sterilmed, Inc. | 2016 | — |
| +1 | K142395 | SC2000 and ACUSON X300 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 1 |
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? (4)
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 |
|---|---|---|---|
| * | — | SOUNDSTAR eco 10F Named without a submission number | |
| * | — | SOUNDSTAR eco 10FG Named without a submission number | |
| * | — | AcuNav UF Named without a submission number | |
| * | — | AcuNav SF0 Named without a submission number |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2015 | Class II | Z-0003-2016 | Device Design | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when… |
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?
- Of its descendants, K250545 (Surgical Instrument Service and Savings, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 as stated in the FDA summary.
https://510kreport.com/device/K140318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140318: Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F 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/K140318
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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