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. · DRA Catheter, Steerable
Cleared on Mar 11, 2005 as substantially equivalent to K041629 (Ekos Corp., 2004) and 1 other predicate after a 15-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Mar 11, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K904788 (1990). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 6 generations between
- 3 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 2 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 1 generation backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- This deviceK050472 Lysus Infusion SystemEkos Corp. · 2005
Show all 10 generations
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 9 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 8 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 7 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 6 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 5 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 4 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 3 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 2 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 1 generation backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- This deviceK050472 Lysus Infusion SystemEkos Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −9 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −8 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −7 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −6 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −5 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −4 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −3 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −2 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −1 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| 0 (this device) | K050472 | Lysus Infusion System | Ekos Corp. | 2005 | — |
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 |
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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K041629 | Lysus Infusion SystemSummary page 1…theter Proprietary Name: Lysus® Infusion System Name of Predicate Device: Lysus® Infusion System 5 10(k) Reference No.: K041629 and K042456 Device Description The system consists of a disposable infusion catheter with removable ultrasound core and an instr… | 2004 |
| * | K042456 | Lysus Infusion SystemSummary page 1…rietary Name: Lysus® Infusion System Name of Predicate Device: Lysus® Infusion System 5 10(k) Reference No.: K041629 and K042456 Device Description The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that g… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 months on median.
- 7 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K041629.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
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/K050472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050472: 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/K050472
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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