510(k) · Cleared
ClearedNUVISION™ NAV Ultrasound Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Feb 16, 2023 as substantially equivalent to K201775 (Nuvera Medical, Inc., 2021) and 1 other predicate after a 63-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Feb 16, 2023
- Review
- 63 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921148 (1992). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 5 generations backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- 4 generations backK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK070242 Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc. · 2007
- 2 generations backK092064 Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc. · 2009
- 1 generation backK112050 Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011
- This deviceK223766 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 1 of 1 · See all- K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −5 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| −4 | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −3 | K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05 | Biosense Webster, Inc. | 2007 | — |
| −2 | K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12 | Biosense Webster, Inc. | 2009 | — |
| −1 | K112050 | Soundstar Eco Diagnostic Ultrasound Catheter | Biosense Webster, Inc. | 2011 | — |
| 0 (this device) | K223766 | NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2023 | — |
| +1 | K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K201775 | NuVision ICE CatheterSummary page 4…ce Manufacturer 510(k) # Decision Date Name NUVISION ICE NuVera Medical, Inc. K201775 March 5, 2021 Catheter, 10F Reference Device Information S… | 2021 |
| * | K112050 | Soundstar Eco Diagnostic Ultrasound CatheterSummary page 4…021 Catheter, 10F Reference Device Information SoundStar eco Biosense Webster, Inc. K112050 Nov 11, 2011 10F Ultrasound Catheter Table 2: Predicate and Referenc… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | 2024 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K241540 (Biosense Webster, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201775.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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™ NAV Ultrasound Catheter and related accessory devices are indicated 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. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. 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/K223766 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223766: NUVISION™ NAV Ultrasound Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223766
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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