510(k) · Cleared
Recalled · 2009Acunav 90/10 Diagnostic 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 Feb 24, 2004 as substantially equivalent to K992631 (Acuson Corp., 1999) after a 96-day review. Its family tree reaches back 2 generations to 1992. 3 of the 949 devices in its family, counting itself, have a Class I recall. 945 later devices descend from it. It has been recalled once.
- Decided
- Feb 24, 2004
- Review
- 96 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921148 (1992). 3 ancestors in all. 945 later devices descend from it, 4 citing it directly. 3 of the 949 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 1 generation backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- This deviceK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 930 of its ownK042593 Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 927 of its ownK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 5 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
Showing 5 of 945 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 945 · See all- K042593Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · cites it directly930descendants
- K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on927descendants
- K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on926descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 4 generations on802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 5 generations on801descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −1 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| 0 (this device) | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K042593 | Acuson Acunav 8F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +3 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +4 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +5 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 16 | 0 |
| 2010 | 16 | 0 |
| 2011 | 28 | 0 |
| 2012 | 30 | 0 |
| 2013 | 41 | 0 |
| 2014 | 45 | 0 |
| 2015 | 53 | 0 |
| 2016 | 60 | 0 |
| 2017 | 76 | 0 |
| 2018 | 65 | 0 |
| 2019 | 49 | 0 |
| 2020 | 73 | 0 |
| 2021 | 53 | 0 |
| 2022 | 57 | 0 |
| 2023 | 58 | 0 |
| 2024 | 67 | 0 |
| 2025 | 80 | 3 |
| 2026 | 55 | 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 |
|---|---|---|---|
| * | K992631 | Acunav Diagnostic Ultrasound CatheterSummary page 2…The AcuNav 90/10 Diagnostic Ultrasound Catheter is substantially equivalent to the ACUSON AcuNav ® 90/10 Diagnostic Ultrasound Catheter (K992631, 11/8/2001). Both catheters are ultrasound-tipped catheter devices used directly within the… | 1999 |
What descends from it? (945)
See all 9454 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- 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
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K042593 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 930 descendants of its own.
- 8 other devices also cite its predicate K992631.
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 AcuNavTM Diagnostic 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.
The AcuNavTM Diagnostic 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.
The AcuNavTM Diagnostic 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/K033650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033650: Acunav 90/10 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/K033650
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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