510(k) · Cleared
ClearedLysus 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 16, 2005 as substantially equivalent to K051319 (Ekos Corp., 2005) after a 15-day review. Its family tree reaches back 11 generations to 1990. 34 later devices descend from it.
- Decided
- Aug 16, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K904788 (1990). 23 ancestors in all. 34 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 7 generations between
- 3 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 2 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 1 generation backK051319 Lysus Infusion SystemEkos Corp. · 2005
- This deviceK052071 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · cites it directly · 27 of its ownK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- Descendant · cites it directly · 17 of its ownK060084 Lysus Infusion SystemEkos Corp. · 2006
- Descendant · 2 generations on · 14 of its ownK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006
- Descendant · 2 generations on · 13 of its ownK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- Descendant · 2 generations on · 13 of its ownK072507 Endowave Infusion SystemEkos Corp. · 2007 · Recalled
Show all 11 generations
- Root · 11 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 10 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 9 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 8 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 7 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 6 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 5 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 4 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 3 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 2 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 1 generation backK051319 Lysus Infusion SystemEkos Corp. · 2005
- This deviceK052071 Lysus Infusion SystemEkos Corp. · 2005
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K060422Lysus Infusion SystemEkos Corp. · 2006 · cites it directly27descendants
- K060084Lysus Infusion SystemEkos Corp. · 2006 · cites it directly17descendants
- K062508Neurowave Micro-Infusion SystemEkos Corp. · 2006 · 2 generations on14descendants
- K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc. · 2016 · 2 generations on13descendants
- K072507Endowave Infusion SystemEkos Corp. · 2007 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −10 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −9 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −8 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −7 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −6 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −5 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −4 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −3 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −2 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −1 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| 0 (this device) | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +1 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
| +1 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| +2 | K062508 | Neurowave Micro-Infusion System | Ekos Corp. | 2006 | — |
| +2 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| +2 | K072507 | Endowave Infusion System | Ekos Corp. | 2007 | 3 |
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 |
|---|---|---|
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 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 |
|---|---|---|---|
| * | K051319 | Lysus Infusion SystemSummary page 5…theter Proprietary Name: Lysus® Infusion System Name of Predicate Device: Lysus® Infusion System 510(k) Reference No.: K051319 Device Description The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that g… | 2005 |
What descends from it? (34)
See all 342 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)
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 15 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 7 of the 23 ancestors have a recall of any class.
- Of its descendants, K060422 (Ekos Corp., 2006) has gone furthest, with 27 descendants 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 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/K052071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052071: Lysus Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052071
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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