510(k) · Cleared
ClearedReprocessed Diagnostic Ultrasound Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Mar 29, 2007 as substantially equivalent to K992631 (Acuson Corp., 1999) after a 174-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Mar 29, 2007
- Review
- 174 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921148 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK921148 Cvis Insight Catheters for Intracardiac UseCardiovascular Imaging Systems, Inc. · 1992
- 1 generation backK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- This deviceK063076 Reprocessed Diagnostic Ultrasound CatheterAscent Healthcare Solutions · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921148 | Cvis Insight Catheters for Intracardiac Use | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −1 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| 0 (this device) | K063076 | Reprocessed Diagnostic Ultrasound Catheter | Ascent Healthcare Solutions | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 K254149 Reprocessed AcuNav CRYSTAL™ Ultrasound…score 13.4 · 7 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 |
|---|---|---|---|
| * | K992631 | Acunav Diagnostic Ultrasound CatheterSummary page 1…Catheter Classification Name: Diagnostic Intravascular Catheter Predicate Device 510(k) Title Manufacturer K992631 AcuNavTM Diagnostic Ultrasound Acuson Corp. Catheter Device description: Diagno… | 1999 |
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 15 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 8 other devices also cite its predicate K992631.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Reprocessed Diagnostic Ultrasound Catheters are indicated for visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The Reprocessed Diagnostic Ultrasound Catheter is intended for use in the right side of the heart only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063076: Reprocessed Diagnostic 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/K063076
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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