510(k) · Cleared
Recalled · 2003Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bacchus Vascular, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Jul 3, 2002 as substantially equivalent to K013635 (Bacchus Vascular, Inc., 2002) after a 19-day review. Its family tree reaches back 4 generations to 1990. 2 of the 66 devices in its family, counting itself, have a Class I recall. 57 later devices descend from it. It has been recalled once.
- Decided
- Jul 3, 2002
- Review
- 19 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904788 (1990). 8 ancestors in all. 57 later devices descend from it, 1 citing it directly. 2 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 3 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 2 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 1 generation backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- This deviceK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002
- Descendant · cites it directly · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- Descendant · 3 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- Descendant · 4 generations on · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004
- Descendant · 5 generations on · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 57 · See all- K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · cites it directly56descendants
- K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 2 generations on50descendants
- K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 3 generations on46descendants
- K041629Lysus Infusion SystemEkos Corp. · 2004 · 4 generations on39descendants
- K042456Lysus Infusion SystemEkos Corp. · 2004 · 5 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −3 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −2 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −1 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| 0 (this device) | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | — |
| +1 | 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 | — |
| +3 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| +4 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| +5 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 1 |
| 2008 | 6 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 1 |
| 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion… | 2002 |
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length) | 2002 | 56 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2003 | Not classified | Z-0816-04 | Other | The device has the potential for fractures at the distal end during use. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K023514 (Bacchus Vascular, Inc., 2002) has gone furthest, with 56 descendants of its own.
- 4 other devices also cite its predicate K013635.
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 TrellisTMPlus Infusion System is intended for 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/K021958 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021958: Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021958
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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