510(k) · Cleared
ClearedAcunav V 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 Sep 26, 2008 after a 92-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.
- Decided
- Sep 26, 2008
- Review
- 92 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 2 citing it directly.
- This deviceK081808 Acunav V Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK163478 AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 2 generations on · 23 of its ownK173618 ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 19 of its ownK181098 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 4 generations on · 9 of its ownK191467 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019
- Descendant · 4 generations on · 8 of its ownK200585 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K163478AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc. · 2017 · cites it directly24descendants
- K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. · 2017 · 2 generations on23descendants
- K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on19descendants
- K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019 · 4 generations on9descendants
- K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081808 | Acunav V Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +1 | K163478 | AcuNav Volume ICE Catheter | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +2 | K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | Siemens Medical Solutions USA, Inc. | 2017 | 1 |
| +3 | K181098 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +4 | K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | 2019 | — |
| +4 | K200585 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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.
Planning a device in OBJ? 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 |
|---|---|---|---|
| * | — | AcuNav Ultrasound Imaging Catheter Named without a submission number |
What descends from it? (26)
See all 262 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163478 (Siemens Medical Solutions USA, Inc., 2017) has gone furthest, with 24 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. 2008, 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 AcuNavTM V 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 Acuson AcuNav V 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 of adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081808 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081808: Acunav V Ultrasound Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081808
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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