510(k) · Decided
DecidedSpeedlyser Infusion Catheter Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Nov 19, 2003 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 41 later devices descend from it.
- Decided
- Nov 19, 2003
- Review
- 21 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 2 citing it directly.
- This deviceK033443 Speedlyser Infusion Catheter KitAngioDynamics, Inc. · 2003
- Descendant · cites it directly · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004
- Descendant · 2 generations on · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- Descendant · 3 generations on · 35 of its ownK051319 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 4 generations on · 34 of its ownK052071 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 5 generations on · 27 of its ownK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K041629Lysus Infusion SystemEkos Corp. · 2004 · cites it directly39descendants
- K042456Lysus Infusion SystemEkos Corp. · 2004 · 2 generations on38descendants
- K051319Lysus Infusion SystemEkos Corp. · 2005 · 3 generations on35descendants
- K052071Lysus Infusion SystemEkos Corp. · 2005 · 4 generations on34descendants
- K060422Lysus Infusion SystemEkos Corp. · 2006 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033443 | Speedlyser Infusion Catheter Kit | AngioDynamics, Inc. | 2003 | — |
| +1 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| +2 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| +3 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +4 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +5 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (41)
See all 412 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?
- Of its descendants, K041629 (Ekos Corp., 2004) has gone furthest, with 39 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 ANGIODYNAMICS SpeedLyser Infusion Catheter and its related components are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033443 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033443: Speedlyser Infusion Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033443
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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