510(k) · Cleared
ClearedAcuNav Crystal Ultrasound 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 28, 2023 as substantially equivalent to K170263 (Siemens Medical Solutions USA, Inc., 2017) after a 29-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Oct 28, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071234 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK071234 Acunav Diagnostic Ultrasound Catheter 8F and 10FSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK170263 AcuNav Diagnostic Ultrasound Catheter 8F,10FSiemens Medical Solutions USA, Inc. · 2017
- This deviceK233270 AcuNav Crystal Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK254149 Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use…Sterilmed, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10F | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| −1 | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | 2017 | — |
| 0 (this device) | K233270 | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2023 | — |
| +1 | K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens… | Sterilmed, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10FSummary page 5…heter CLASSIFICATION NAME/PRODUCT CODE Diagnostic Intravascular Catheter/ OBJ CLASSIFICATION Class II, 21 CFR 870.1200 PREDICATE DEVICE #K170263, AcuNav Diagnostic Ultrasound Catheter 8F, 10F DESCRIPTION OF MODIFIED DEVICE The AcuNav Crystal Ultrasound catheter… | 2017 |
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 |
|---|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System… | 2026 | 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 16 years and passes through 1 company; a new generation was cleared every 10.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K254149 (Sterilmed, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K170263.
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 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/K233270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233270: AcuNav Crystal Ultrasound Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233270
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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