510(k) · Cleared
ClearedUNI*FUSE Infusion System with Cooper Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Jun 1, 2020 as substantially equivalent to K183290 (Thrombolex, Inc., 2019) after a 238-day review. Its family tree reaches back 19 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 1, 2020
- Review
- 238 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K904788 (1990). 50 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 15 generations between
- 3 generations backK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- 2 generations backK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- 1 generation backK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- This deviceK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK202347 UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK251318 VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 18 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 17 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 16 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 15 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 14 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 13 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 12 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 11 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 10 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 9 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 8 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 7 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 6 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 5 generations backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- 4 generations backK073166 Endowave Infusion SystemEkos Corp. · 2008
- 3 generations backK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- 2 generations backK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- 1 generation backK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- This deviceK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
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 |
|---|---|---|---|---|---|
| −19 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −18 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −17 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −16 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −15 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −14 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −13 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −12 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −11 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −10 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −9 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −8 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −7 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| −6 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| −5 | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| −4 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| −3 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
| −2 | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | 5 |
| −1 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| 0 (this device) | K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
| +1 | K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
| +2 | K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Summary page 5…Cardiovascular Devices Predicate Device 510(k) Reference K183290 Trade Name: Thrombolex, Inc. Bashir™ and Bashir™ N‐X Endovascular Catheters Common Name:… | 2019 |
| † | K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | 2017 |
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 |
|---|---|---|---|
| K202347 | UNIFUSE Infusion System with Cooper Wire | 2020 | 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 30 years and passes through 7 companies; a new generation was cleared every 8 months on median.
- 12 of the 50 ancestors have a recall of any class.
- Of its descendants, K202347 (AngioDynamics, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K183290.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 UNI*FUSE™ Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.
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/K192864 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192864: UNI*FUSE Infusion System with Cooper Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192864
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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