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 6, 2004 as substantially equivalent to K033214 (Ekos Corp., 2003) and 5 other predicates after a 51-day review. Its family tree reaches back 8 generations to 1990. 39 later devices descend from it.
- Decided
- Aug 6, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K904788 (1990). 20 ancestors in all. 39 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 7 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 6 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 5 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 4 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 3 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 2 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 1 generation backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- This deviceK041629 Lysus Infusion SystemEkos Corp. · 2004
- Descendant · cites it directly · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- Descendant · 2 generations on · 35 of its ownK051319 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 3 generations on · 34 of its ownK052071 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 4 generations on · 27 of its ownK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- Descendant · 4 generations on · 17 of its ownK060084 Lysus Infusion SystemEkos Corp. · 2006
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K042456Lysus Infusion SystemEkos Corp. · 2004 · cites it directly38descendants
- K051319Lysus Infusion SystemEkos Corp. · 2005 · 2 generations on35descendants
- K052071Lysus Infusion SystemEkos Corp. · 2005 · 3 generations on34descendants
- K060422Lysus Infusion SystemEkos Corp. · 2006 · 4 generations on27descendants
- K060084Lysus Infusion SystemEkos Corp. · 2006 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −7 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −6 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −5 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −4 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −3 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −2 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −1 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| 0 (this device) | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| +1 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| +2 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +3 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +4 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
| +4 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| Kept off the family tree | K030367 | FDA’s K030367 is Columbus (PS) Our reading of the summary gave K030367, FDA’s number for Columbus (PS) (Aesculap, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EKOS Peripheral Infusion System”. Kept off the family tree. Summary page 5…legally marketed devices. These devices include * EKOS Corporation: EKOS Peripheral Infusion System (K(030367, K(0332 14) * Merit Medical: Fountain Infusion Catheter (K(974067, K991619, K(9… | 2003 |
| * | K033214 | Ekos Peripheral Infusion System | 2003 |
| * | K974067 | Fountain Infusion Catheter and Occluding Guide WireSummary page 5…EKOS Corporation: EKOS Peripheral Infusion System (K(030367, K(0332 14) * Merit Medical: Fountain Infusion Catheter (K(974067, K991619, K(992231) * Micro Therapeutics: Cragg/McNamara Infusion Catheter… | 1998 |
| * | K991619 | FOUNTAIN Infusion Catheter and Occluding Guide WireSummary page 5…rporation: EKOS Peripheral Infusion System (K(030367, K(0332 14) * Merit Medical: Fountain Infusion Catheter (K(974067, K991619, K(992231) * Micro Therapeutics: Cragg/McNamara Infusion Catheter… | 1999 |
| * | K992231 | FOUNTAIN Infusion Catheter and Occluding Guide WireSummary page 5…stem (K(030367, K(0332 14) * Merit Medical: Fountain Infusion Catheter (K(974067, K991619, K(992231) * Micro Therapeutics: Cragg/McNamara Infusion Catheter (K964868)… | 1999 |
| * | K964868 | 2.9F Cragg-Mcnamara Valved Infusion CatheterSummary page 5…theter (K(974067, K991619, K(992231) * Micro Therapeutics: Cragg/McNamara Infusion Catheter (K964868) * Angiodynamics: SpeedLyser Infusion Catheter Kit (K(033443) Performance: EKOS has conducted… | 1997 |
| * | K033443 | Speedlyser Infusion Catheter KitSummary page 5…* Micro Therapeutics: Cragg/McNamara Infusion Catheter (K964868) * Angiodynamics: SpeedLyser Infusion Catheter Kit (K(033443) Performance: EKOS has conducted preclinical bench and animal studies with the Lysus® Infus… | 2003 |
What descends from it? (39)
See all 392 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 14 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 6 of the 20 ancestors have a recall of any class.
- Of its descendants, K042456 (Ekos Corp., 2004) has gone furthest, with 38 descendants of its own.
- 1 other device also cites its predicate K033214.
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/K041629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041629: 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/K041629
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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