510(k) · Cleared
ClearedResolution Endovascular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnisonics Medical Technologies · QEY Mechanical Thrombolysis Catheter
Cleared on Dec 8, 2005 as substantially equivalent to K041705 (Omnisonics Medical Technologies, 2004) after a 97-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 8, 2005
- Review
- 97 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970080 (1997). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970080 Arrow-Trerotola PTD CatheterArrow Intl., Inc. · 1997
- 1 generation backK041705 Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies · 2004
- This deviceK052428 Resolution Endovascular SystemOmnisonics Medical Technologies · 2005
- Descendant · cites it directly · 1 of its ownK071762 Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007
- Descendant · 2 generations on · 0 of its ownK083335 Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970080 | Arrow-Trerotola PTD Catheter | Arrow Intl., Inc. | 1997 | — |
| −1 | K041705 | Resolution Thrombectomy System, Model EV-2 | Omnisonics Medical Technologies | 2004 | — |
| 0 (this device) | K052428 | Resolution Endovascular System | Omnisonics Medical Technologies | 2005 | — |
| +1 | K071762 | Omniwave Endovascular System | Omnisonics Medical Technologies | 2007 | — |
| +2 | K083335 | Modified Omniwave Endovascular System | Omnisonics Medical Technologies | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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 QEY? 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 QEY device
- #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 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 |
|---|---|---|---|
| * | K041705 | Resolution Thrombectomy System, Model EV-2Summary page 5…ugust 30, 2005 Trade Name: Resolution® Endovascular System Classification Name: CFR §870.5151, Embolectomy Catheter Predicate Devices: Resolution® Thrombectomy System — K041705 Device Description: The Resolution Endovascular System is a portable ultrasound energy system for the treatment of thrombosed s… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071762 | Omniwave Endovascular System | 2007 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K071762 (Omnisonics Medical Technologies, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEY
62in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEY
5in 2025
MAUDE reports naming product code QEY, 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 | 5 | 28 | 0 | 0 |
| 2008 | 4 | 54 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | 144 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 5 | 91 | 0 | 0 |
| 2020 | 3 | 158 | 0 | 0 |
| 2021 | 3 | 62 | 0 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Omnisonics Resolution® Endovascular System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.
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/K052428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052428: Resolution Endovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052428
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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