510(k) · Cleared
Recalled · 2007Lysus 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 Mar 9, 2006 as substantially equivalent to K052071 (Ekos Corp., 2005) after a 20-day review. Its family tree reaches back 12 generations to 1990. 27 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K904788 (1990). 24 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 8 generations between
- 3 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 2 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 1 generation backK052071 Lysus Infusion SystemEkos Corp. · 2005
- This deviceK060422 Lysus Infusion SystemEkos Corp. · 2006
- Descendant · cites it directly · 13 of its ownK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK071933 Endowave Infusion SystemEkos Corp. · 2007
- Descendant · 2 generations on · 11 of its ownK073166 Endowave Infusion SystemEkos Corp. · 2008
- Descendant · 2 generations on · 10 of its ownK163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty…Shockwave Medical, Inc. · 2016
- Descendant · 3 generations on · 10 of its ownK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
Show all 12 generations
- Root · 12 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 11 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 10 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 9 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 8 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 7 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 6 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 5 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 4 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 3 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 2 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 1 generation backK052071 Lysus Infusion SystemEkos Corp. · 2005
- This deviceK060422 Lysus Infusion SystemEkos Corp. · 2006
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc. · 2016 · cites it directly13descendants
- K071933Endowave Infusion SystemEkos Corp. · 2007 · cites it directly12descendants
- K073166Endowave Infusion SystemEkos Corp. · 2008 · 2 generations on11descendants
- K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc. · 2016 · 2 generations on10descendants
- K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −11 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −10 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −9 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −8 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −7 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −6 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −5 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −4 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −3 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −2 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −1 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| 0 (this device) | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| +1 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| +1 | K071933 | Endowave Infusion System | Ekos Corp. | 2007 | — |
| +2 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| +2 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And… | Shockwave Medical, Inc. | 2016 | — |
| +3 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K052071 | Lysus Infusion SystemSummary page 5…Namei: Lvsus®k Infusion System Name of Predicate Device: LysusX® Infusion Systbm 5 10(k) Refecrenc No.: K052071I Device Description TI-e system consists ofa disposable infusion catheter with removable ultrasound core and an instrument that… | 2005 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2007 | Not classified | Z-0577-2007 | Other | Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 7 of the 24 ancestors have a recall of any class.
- Of its descendants, K161384 (Shockwave Medical, Inc., 2016) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K052071.
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 Lysus® Infusion System is intended for the controlled and
selective infusion of physician-specified fluids, including thrombolytics, into the
peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060422: Lysus Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060422
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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