510(k) · Cleared
ClearedAcuNav Diagnostic Ultrasound Catheter 8F,10F
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 Jun 15, 2017 as substantially equivalent to K071234 (Siemens Medical Solutions USA, Inc., 2007) after a 139-day review. Its family tree reaches back 1 generation to 2007. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Jun 15, 2017
- Review
- 139 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071234 (2007). 6 later devices descend from it, 4 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK071234 Acunav Diagnostic Ultrasound Catheter 8F and 10FSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK170263 AcuNav Diagnostic Ultrasound Catheter 8F,10FSiemens Medical Solutions USA, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK233270 AcuNav Crystal Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK200812 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight…Philips Image Guided Therapy Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK254149 Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use…Sterilmed, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251103 VeriSight Intracardiac Echocardiography Catheter (VSICE2D)…Philips Image Guided Therapy Corporation · 2025
- Descendant · cites it directly · 0 of its ownK243101 Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound…Surgical Instrument Service and Savings, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K234064 Medline ReNewal Reprocessed Siemens ACUSON…cites it directly · 2024
Most influential descendants
Showing 5 of 6 · See all- K233270AcuNav Crystal Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2023 · cites it directly1descendant
- K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterPhilips Image Guided Therapy Corporation · 2020 · cites it directly1descendant
- K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc. · 2026 · 2 generations on0descendants
- K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…Philips Image Guided Therapy Corporation · 2025 · 2 generations on0descendants
- K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens…Surgical Instrument Service and Savings, Inc. · 2025 · cites it directly0descendants
View 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) | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +1 | K233270 | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2023 | — |
| +1 | K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE… | Philips Image Guided Therapy Corporation | 2020 | — |
| +2 | K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens… | Sterilmed, Inc. | 2026 | — |
| +2 | K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro… | Philips Image Guided Therapy Corporation | 2025 | — |
| +1 | K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for… | Surgical Instrument Service and Savings, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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…10F COMMON NAME Ultrasound Catheter CLASSIFICATION NAME/PRODUCT CODE Intravascular Ultrasound Catheter/OBJ CLASSIFICATION Class II, 21 CFR 870.1200 PREDICATE DEVICE #K071234, ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10 DESCRIPTION OF MODIFIED DEVICE The AcuNav catheters are, disposable, and lice… | 2007 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233270 | AcuNav Crystal Ultrasound Catheter | 2023 | 1 |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | 2020 | 1 |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens… | 2025 | 0 |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens… Class I | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936)…Surgical Instrument Service and Savings, Inc. · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
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. 2017, 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 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. 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/K170263 · printed Nov 3, 2026
Cite this page
510(k) Report. “K170263: AcuNav Diagnostic Ultrasound Catheter 8F,10F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170263
Report an extraction error
Are you the manufacturer?
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