510(k) · Cleared
ClearedModified Omniwave 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 15, 2008 as substantially equivalent to K071762 (Omnisonics Medical Technologies, 2007) after a 33-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Dec 15, 2008
- Review
- 33 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K904788 (1990). 59 ancestors in all, the oldest K873004 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 6 generations between
- 3 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 2 generations backK050563 Ekos Peripheral Infusion SystemEkos Corp. · 2005
- 1 generation backK071762 Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007
- This deviceK083335 Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008
Show all 10 generations
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 9 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 8 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 7 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 6 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 5 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 4 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 3 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 2 generations backK050563 Ekos Peripheral Infusion SystemEkos Corp. · 2005
- 1 generation backK071762 Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007
- This deviceK083335 Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −9 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −8 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −7 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −6 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −5 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −4 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −3 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −2 | K050563 | Ekos Peripheral Infusion System | Ekos Corp. | 2005 | — |
| −1 | K071762 | Omniwave Endovascular System | Omnisonics Medical Technologies | 2007 | — |
| 0 (this device) | K083335 | Modified Omniwave Endovascular System | Omnisonics Medical Technologies | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 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 |
|---|---|---|---|
| * | K071762 | Omniwave Endovascular SystemSummary page 5…mniwave Endovascular System Classification Name: CFR §870.1210, Catheter, Continuous Flush Predicate Device: Omniwave Endovascular System K07 1762 Device Description: The Modified Ornniwave Endovascular System is comprised of two major components: (1) the sterile, single use… | 2007 |
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 18 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 59 ancestors have a recall of any class.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Modified Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083335: Modified Omniwave Endovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083335
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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