510(k) · Cleared
ClearedNuVision ICE Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvera Medical, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Mar 5, 2021 as substantially equivalent to K071234 (Siemens Medical Solutions USA, Inc., 2007) after a 249-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Mar 5, 2021
- Review
- 249 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071234 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK071234 Acunav Diagnostic Ultrasound Catheter 8F and 10FSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK201775 NuVision ICE CatheterNuvera Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK223766 NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK241540 NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10F | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| 0 (this device) | K201775 | NuVision ICE Catheter | Nuvera Medical, Inc. | 2021 | — |
| +1 | K223766 | NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2023 | — |
| +1 | K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10FSummary page 4…OBJ) Class: Class II Panel: Division of Cardiovascular Devices Predicate Device: AcuNav™ Diagnostic Ultrasound Catheter (K071234) Device Description The NuVision ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. The cath… | 2007 |
What descends from it? (2)
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?
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 NuVision ICE 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/K201775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201775: NuVision 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/K201775
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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