510(k) · Cleared
Recalled · 2009Acunav Diagnostic Ultrasound Catheter 8F and 10F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Jun 29, 2007 after a 57-day review. The FDA summary names its predicate without a number. 3 of the 357 devices in its family, counting itself, have a Class I recall. 356 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 1
- Predicates
- 0
356 later devices descend from it, 11 citing it directly. 3 of the 357 devices in this family, counting this one, have a Class I recall.
- This deviceK071234 Acunav Diagnostic Ultrasound Catheter 8F and 10FSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 223 of its ownK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · cites it directly · 198 of its ownK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- Descendant · cites it directly · 192 of its ownK112596 Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011
- Descendant · 2 generations on · 177 of its ownK130739 Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013
- Descendant · 2 generations on · 124 of its ownK131164 AcusonSiemens Medical Solutions USA, Inc. · 2013
Showing 5 of 356 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 356 · See all- K111674AcusonSiemens Medical Solutions USA, Inc. · 2011 · cites it directly223descendants
- K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012 · cites it directly198descendants
- K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011 · cites it directly192descendants
- K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on177descendants
- K131164AcusonSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on124descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10F | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| +1 | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| +1 | K112596 | Acuson S2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2011 | — |
| +2 | K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +2 | K131164 | Acuson | Siemens Medical Solutions USA, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 13 | 0 |
| 2015 | 19 | 0 |
| 2016 | 24 | 0 |
| 2017 | 31 | 0 |
| 2018 | 29 | 0 |
| 2019 | 29 | 0 |
| 2020 | 27 | 0 |
| 2021 | 28 | 0 |
| 2022 | 27 | 0 |
| 2023 | 27 | 1 |
| 2024 | 29 | 1 |
| 2025 | 32 | 1 |
| 2026 | 16 | 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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | — | original AcuNav Ultrasound Imaging Catheter Named without a submission number |
What descends from it? (356)
See all 35611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111674 | Acuson | 2011 | 223 |
| K121138 | Acuson S3000 Diagnostic Ultrasound System | 2012 | 198 |
| K112596 | Acuson S2000 Diagnostic Ultrasound System | 2011 | 192 |
| K133853 | Viewflex Xtra Ice Catheter | 2014 | 14 |
| K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12 | 2009 | 9 |
| K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | 2017 | 6 |
| K201775 | NuVision ICE Catheter | 2021 | 2 |
| K153090 | Reprocessed Diagnostic Ultrasound Catheter | 2016 | 1 |
| K250955 | XC11 ICE System, USA | 2025 | 0 |
| K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | 2017 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2009 | Not classified | Z-1745-2011 | Process design | Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers. |
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.
- K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936)…Surgical Instrument Service and Savings, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
- K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K111674 (Siemens Medical Solutions USA, Inc., 2011) has gone furthest, with 223 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. 2007, 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 Acuson Acunav Ultrsound Catheter is intended 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 of adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071234
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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