510(k) · Cleared
ClearedSquirt Fluid Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Jul 17, 1998 as substantially equivalent to K974067 (Merit Medical Systems, Inc., 1998) after an 88-day review. Its family tree reaches back 2 generations to 1990. 2 of the 99 devices in its family, counting itself, have a Class I recall. 95 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904788 (1990). 3 ancestors in all. 95 later devices descend from it, 3 citing it directly. 2 of the 99 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 1 generation backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- This deviceK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- Descendant · cites it directly · 75 of its ownK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- Descendant · 2 generations on · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- Descendant · 4 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 95 · See all- K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc. · 2002 · cites it directly75descendants
- K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · 2 generations on57descendants
- K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · 2 generations on56descendants
- K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 3 generations on50descendants
- K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 4 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −1 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| 0 (this device) | 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 | — |
| +2 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| +2 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| +3 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| +4 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 7 | 1 |
| 2008 | 8 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 1 |
| 2014 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K974067 | Fountain Infusion Catheter and Occluding Guide Wire Our reading of the summary gave “K974067.” beside “510(k)”; FDA’s K974067 is the only number that fits it and carries the summary’s name for the device. Summary page 6…c and has a one year shelf life. The Squirt™ is intended to be sold as a stand alone device or with the Fountain™ Infusion System, which was cleared under Merit's 510(k) K974067. MERIT M… | 1998 |
| * | — | Merit Medical Medallion™ Syringe Named without a submission number | |
| * | — | Merit Medical Check Relief Valve Named without a submission number |
What descends from it? (95)
See all 953 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 8 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K013635 (Bacchus Vascular, Inc., 2002) has gone furthest, with 75 descendants of its own.
- 5 other devices also cite its predicate K974067.
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 Squirt™ Fluid Delivery System is intended for the controlled administration of
thrombolytic agents into the peripheral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981417: Squirt Fluid Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981417
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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