510(k) · Cleared
ClearedInfusioncath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Id, LLC · QEY Mechanical Thrombolysis Catheter
Cleared on Aug 5, 2004 as substantially equivalent to K013635 (Bacchus Vascular, Inc., 2002) and 2 other predicates after a 59-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Aug 5, 2004
- Review
- 59 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904788 (1990). 9 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- 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 deviceK041517 InfusioncathId, LLC · 2004
- Descendant · cites it directly · 1 of its ownK052738 Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016…Veinrx, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK073400 Varicath Peripheral Infusion CatheterVeinrx, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK052844 Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG · 2006
Most influential descendants
Showing 3 of 3 · See all- K052738Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028…Veinrx, Inc. · 2005 · cites it directly1descendant
- K073400Varicath Peripheral Infusion CatheterVeinrx, Inc. · 2007 · cites it directly0descendants
- K052844Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG · 2006 · cites it directly0descendants
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) | K041517 | Infusioncath | Id, LLC | 2004 | — |
| +1 | K052738 | Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024… | Veinrx, Inc. | 2005 | — |
| +1 | K073400 | Varicath Peripheral Infusion Catheter | Veinrx, Inc. | 2007 | — |
| +1 | K052844 | Kavs - Catheter, Models 1107100 & 1107060 | Richter & Rothe AG | 2006 | — |
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 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 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? (3)
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…Summary page 5…The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature. Predicate Devices K013635 Trellis Infusion System Bacchus Vascular, Inc. K992940 LeMaitre Balloon Catheter with I… | 2002 |
| * | K992940 | Lemaitre Balloon Catheter with IrrigationSummary page 5…uding thrombolytics, into the peripheral vasculature. Predicate Devices K013635 Trellis Infusion System Bacchus Vascular, Inc. K992940 LeMaitre Balloon Catheter with Irrigation Vascutech, Inc. K913517 Isolate Infusion Cath… | 2000 |
| * | K913517 | Isolate Infusion Cathetr SystemSummary page 5…s Infusion System Bacchus Vascular, Inc. K992940 LeMaitre Balloon Catheter with Irrigation Vascutech, Inc. K913517 Isolate Infusion Catheter Lake Region, Inc. Device Description The VeinRx InfusionCath is use… | 1991 |
What descends from it? (3)
3 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 3.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K052738 (Veinrx, Inc., 2005) has gone furthest, with 1 descendant 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 InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041517: Infusioncath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041517
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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