510(k) · Cleared
ClearedACUSON AcuNav Volume Intracardiac Echocardiography (ICE) 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, 2021 as substantially equivalent to K203726 (Siemens Medical Solutions USA, Inc., 2021) after a 29-day review. Its family tree reaches back 4 generations to 2008. 4 later devices descend from it.
- Decided
- Oct 15, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K081808 (2008). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK081808 Acunav V Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2008
- 3 generations backK163478 AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc. · 2017
- 2 generations backK173618 ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- 1 generation backK203726 ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSiemens Medical Solutions USA, Inc. · 2021
- This deviceK212959 ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSiemens Medical Solutions USA, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK242893 VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited · 2025
- Descendant · cites it directly · 0 of its ownK261696 ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261849 VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited · 2026
- Descendant · 2 generations on · 0 of its ownK260885 VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited · 2026
Most influential descendants
Showing 4 of 4 · See all- K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited · 2025 · cites it directly2descendants
- K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026 · cites it directly0descendants
- K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited · 2026 · 2 generations on0descendants
- K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K081808 | Acunav V Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −3 | 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 |
| −1 | K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter | Siemens Medical Solutions USA, Inc. | 2021 | — |
| 0 (this device) | K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +1 | K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | 2025 | — |
| +1 | K261696 | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | 2026 | — |
| +2 | K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026 | — |
| +2 | K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSummary page 4…nd Catheter CLASSIFICATION NAME/PRODUCT CODE Diagnostic Intravascular Catheter/ OBJ CLASSIFICATION Class II, 21 CFR 870.1200 PREDICATE DEVICE #K203726, ACUSON AcuNav Volume Intracardiac Echocardiography Catheter DESCRIPTION OF MODIFIED DEVICE The ACUSON AcuNav Volume In… | 2021 |
What descends from it? (4)
2 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?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K242893 (Luma Vision Limited, 2025) has gone furthest, with 2 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. 2021, 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 catheter is intended for intracardiac 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.
The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212959: ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212959
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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