510(k) · Decided
DecidedEkos Micro-Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekos Corp. · QEY Mechanical Thrombolysis Catheter
Cleared on Aug 6, 2007 as substantially equivalent to K053437 (Ekos Corp., 2006) and 7 other predicates after a 244-day review. Its family tree reaches back 14 generations to 1990. 12 later devices descend from it.
- Decided
- Aug 6, 2007
- Review
- 244 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 14 generations to K904788 (1990). 37 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 10 generations between
- 3 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 2 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 1 generation backK062507 Micro-Infusion SystemEkos Corp. · 2006
- This deviceK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- Descendant · cites it directly · 11 of its ownK073166 Endowave Infusion SystemEkos Corp. · 2008
- Descendant · 2 generations on · 10 of its ownK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- Descendant · 3 generations on · 9 of its ownK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- Descendant · 4 generations on · 8 of its ownK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 13 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 12 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 11 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 10 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 9 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 8 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 7 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 6 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 5 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 4 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 3 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 2 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 1 generation backK062507 Micro-Infusion SystemEkos Corp. · 2006
- This deviceK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K073166Endowave Infusion SystemEkos Corp. · 2008 · cites it directly11descendants
- K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · 2 generations on10descendants
- K111705Ekosonic Endovascular SystemEkos Corporation · 2011 · 3 generations on9descendants
- K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019 · 4 generations on8descendants
- K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −13 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −12 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −11 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −10 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −9 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −8 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −7 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −6 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −5 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −4 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −3 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −2 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| −1 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| 0 (this device) | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| +1 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| +2 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
| +3 | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | 5 |
| +4 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| +5 | K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
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 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053437 | Ekos Micro-Infusion SystemSummary page 5…ially equivalent to other legally marketed devices. These devices include: EKOS Micro-Infusion System, (EKOS Corporation, K053437, K053432, K062507, K062508) Endeavor Infusion Catheter, (Cordis Corporation, K… | 2006 |
| * | K053432 | Ekos Micro-Infusion SystemSummary page 5…other legally marketed devices. These devices include: EKOS Micro-Infusion System, (EKOS Corporation, K053437, K053432, K062507, K062508) Endeavor Infusion Catheter, (Cordis Corporation, K9721 10)… | 2005 |
| * | K062507 | Micro-Infusion SystemSummary page 5…ther legally marketed devices. These devices include: EKOS Micro-Infusion System, (EKOS Corporation, K053437, K053432, K062507, K062508) Endeavor Infusion Catheter, (Cordis Corporation, K9721 10)… | 2006 |
| * | K062508 | Neurowave Micro-Infusion SystemSummary page 5…lly marketed devices. These devices include: EKOS Micro-Infusion System, (EKOS Corporation, K053437, K053432, K062507, K062508) Endeavor Infusion Catheter, (Cordis Corporation, K9721 10) CONFIDENT… | 2006 |
| * | K972110 | Cordis Endeavor Infusion CatheterSummary page 5…fusion System, (EKOS Corporation, K053437, K053432, K062507, K062508) Endeavor Infusion Catheter, (Cordis Corporation, K9721 10) CONFIDENTIAL Page 24 EKOS Micro-Infusion Sy… | 1997 |
| Kept off the family tree | K944004 | FDA’s K944004 is Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) Our reading of the summary gave K944004, FDA’s number for Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) (Endosonics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PV 0.018 F/X”. Kept off the family tree. Summary page 6…Page 24 EKOS Micro-Infusion System 510(k) Notification PV 0.018 F/X, (JoMed, K944004) Renegade Hi-Flo Microcatheter, (Boston Scientific Corporation, K000177)… | 1995 |
| * | K000177 | Renegade HI-Flo MicrocatheterSummary page 6…ation PV 0.018 F/X, (JoMed, K944004) Renegade Hi-Flo Microcatheter, (Boston Scientific Corporation, K000177) TurboTracker 18 Infusion Catheter, (Boston Scientific Corporation, K960806)… | 2000 |
| * | K960806 | Turbo TrackerSummary page 6…on Scientific Corporation, K000177) TurboTracker 18 Infusion Catheter, (Boston Scientific Corporation, K960806) FasTracker 10 Infusion Catheter, (Boston Scientific Corporation, K926243) Performa… | 1996 |
| * | K926243 | Angiographic CatheterSummary page 6…ston Scientific Corporation, K960806) FasTracker 10 Infusion Catheter, (Boston Scientific Corporation, K926243) Performance: EKOS has conducted preclinical bench and animal studies with the Micro-Infusion System. T… | 1993 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073166 | Endowave Infusion System | 2008 | 11 |
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 17 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 8 of the 37 ancestors have a recall of any class.
- Of its descendants, K073166 (Ekos Corp., 2008) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K053437.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 EKOS Micro-Infision System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels. The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature. WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic…
Read the full statement (105 words)
The EKOS Micro-Infision System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels.
The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.
WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063620 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063620: Ekos Micro-Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063620
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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