510(k) · Cleared
ClearedReprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Jun 29, 2026 as substantially equivalent to K240050 (Biosense Webster, Inc., 2024) and 1 other predicate after a 189-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jun 29, 2026
- Review
- 189 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921148 (1992). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 6 generations backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- 5 generations backK033650 Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK070242 Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc. · 2007
- 3 generations backK092064 Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc. · 2009
- 2 generations backK112050 Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011
- 1 generation backK240050 SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc. · 2024
- This deviceK254149 Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use…Sterilmed, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −6 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| −5 | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −4 | K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05 | Biosense Webster, Inc. | 2007 | — |
| −3 | K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12 | Biosense Webster, Inc. | 2009 | — |
| −2 | K112050 | Soundstar Eco Diagnostic Ultrasound Catheter | Biosense Webster, Inc. | 2011 | — |
| −1 | K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | 2024 | — |
| 0 (this device) | K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens… | Sterilmed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 OWQ? 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 OWQ device
- #1 K231588 ViewFlex™ Eco Reprocessed ICE Catheterscore 9.8 · 5 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 |
|---|---|---|---|
| * | K240050 | SOUNDSTAR™ CRYSTAL Ultrasound CatheterSummary page 6…ss II, 21 CFR 870.1200 Product Code: OWQ Primary Predicate Biosense Webster SOUNDSTAR CRYSTAL™ Ultrasound Catheter Device: (K240050) Secondary Predicate Siemens AcuNav CRYSTAL™ Ultrasound Catheter (K233270) Devices: Device Description: The Rep… | 2024 |
| * | K233270 | AcuNav Crystal Ultrasound CatheterSummary page 6…Biosense Webster SOUNDSTAR CRYSTAL™ Ultrasound Catheter Device: (K240050) Secondary Predicate Siemens AcuNav CRYSTAL™ Ultrasound Catheter (K233270) Devices: Device Description: The Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter is a 9F… | 2023 |
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 34 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 12 ancestors have a recall of any class.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OWQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWQ
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWQ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWQ
42in 2025
MAUDE reports naming product code OWQ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 3 | 261 | 0 | 9 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 38 |
| 2022 | 2 | — | 0 | 24 |
| 2023 | 8 | 78 | 0 | 29 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 3 | 100 | 2 | 42 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter is 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 compatible CARTO 3 EP Navigation Systems, the catheter provides location information. Refer to the Biosense Webster Compatibility Matrix Insert for compatible CARTO 3 Systems as each catheter is compatible with a…
Read the full statement (139 words)
The Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter is 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 compatible CARTO 3 EP Navigation Systems, the catheter provides location information. Refer to the Biosense Webster Compatibility Matrix Insert for compatible CARTO 3 Systems as each catheter is compatible with a specific version of the CARTO 3 System and is not backward compatible with previous versions of the CARTO 3 EP Navigation System.
The Reprocessed AcuNav CRYSTAL Ultrasound 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/K254149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254149: Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254149
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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