510(k) · Cleared
ClearedACUNAV Luxera 4D 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 Sep 10, 2026 as substantially equivalent to K212959 (Siemens Medical Solutions USA, Inc., 2021) after a 111-day review. Its family tree reaches back 5 generations to 2008.
- Decided
- Sep 10, 2026
- Review
- 111 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K081808 (2008). No later device cites it as a predicate yet.
- Root · 5 generations backK081808 Acunav V Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2008
- 4 generations backK163478 AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc. · 2017
- 3 generations backK173618 ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- 2 generations backK203726 ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSiemens Medical Solutions USA, Inc. · 2021
- 1 generation backK212959 ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSiemens Medical Solutions USA, Inc. · 2021
- This deviceK261696 ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K081808 | Acunav V Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −4 | K163478 | AcuNav Volume ICE Catheter | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −3 | K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | Siemens Medical Solutions USA, Inc. | 2017 | 1 |
| −2 | K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter | Siemens Medical Solutions USA, Inc. | 2021 | — |
| −1 | K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter | Siemens Medical Solutions USA, Inc. | 2021 | — |
| 0 (this device) | K261696 | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSummary page 5…heter CLASSIFICATION NAME/PRODUCT CODE Diagnostic Intravascular Catheter/ OBJ CLASSIFICATION Class II, 21 CFR 870.1200 PREDICATE DEVICE #K212959, ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter DESCRIPTION OF MODIFIED DEVICE The ACUNAV Luxera 4D… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K212959.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261696: ACUNAV Luxera 4D 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/K261696
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026