510(k) · Cleared
ClearedAcuson Acunav 8F Ultrasound Catheter
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 Oct 15, 2004 as substantially equivalent to K033650 (Siemens Medical Solutions USA, Inc., 2004) and 2 other predicates after a 22-day review. Its family tree reaches back 3 generations to 1992. 2 of the 936 devices in its family, counting itself, have a Class I recall. 930 later devices descend from it.
- Decided
- Oct 15, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921148 (1992). 5 ancestors in all. 930 later devices descend from it, 3 citing it directly. 2 of the 936 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 2 generations backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- 1 generation backK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- This deviceK042593 Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 927 of its ownK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 4 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- Descendant · 5 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 930 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 930 · See all- K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly927descendants
- K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on926descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 4 generations on801descendants
- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 5 generations on800descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −2 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| −1 | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| 0 (this device) | K042593 | Acuson Acunav 8F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +2 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +3 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +4 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| +5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 13 | 0 |
| 2010 | 15 | 0 |
| 2011 | 26 | 0 |
| 2012 | 30 | 0 |
| 2013 | 41 | 0 |
| 2014 | 45 | 0 |
| 2015 | 53 | 0 |
| 2016 | 59 | 0 |
| 2017 | 75 | 0 |
| 2018 | 65 | 0 |
| 2019 | 49 | 0 |
| 2020 | 73 | 0 |
| 2021 | 53 | 0 |
| 2022 | 57 | 0 |
| 2023 | 57 | 0 |
| 2024 | 65 | 0 |
| 2025 | 79 | 2 |
| 2026 | 54 | 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.
2 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? (3)
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 |
|---|---|---|---|
| * | K033650 | Acunav 90/10 Diagnostic Ultrasound CatheterSummary page 7…substantially equivalent to our current product that is already cleared for USA distribution under the following 5 10(k) PreMarket Notification numbers: * # K033650 (February 24, 2004), cleared as ACUSON AcuNav 90/10 Diagnostic Ultrasound Catheter. · # K992631 (November… | 2004 |
| * | K992631 | Acunav Diagnostic Ultrasound CatheterSummary page 4…System: Cypress Transducer: AcuNav 8F Ultrasound Catheter P=Previously cleared by the FDA undcr prcmarke( notification K99263 1. Additional Conln~ents: *The Cypress Ultrasound System does not r~rovidccomhincd ~ n o & s . x h e ~ - s… | 1999 |
| * | K010950 | Cypress SystemSummary page 7…Diagnostic Ultrasound Catheter. · # K992631 (November 8, 2001), cleared as ACUSON AcuNav Diagnostic Ultrasound Catheter. * #K010950 (June 27, 2001), cleared as Cypress Ultrasound System with AcuNav Diagnostic Ultrasound Catheter. The AcuNav 8F… | 2001 |
What descends from it? (930)
See all 9303 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K050240 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 927 descendants of its own.
- 3 other devices also cite its predicate K033650.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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™ Ultrasound 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.
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/K042593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042593: Acuson Acunav 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/K042593
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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