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 Oct 31, 2016 as substantially equivalent to K981417 (Merit Medical Systems, Inc., 1998) after a 28-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 31, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904788 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 2 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 1 generation backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- This deviceK162777 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −2 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −1 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K162777 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (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 |
|---|---|---|---|
| * | K981417 | Squirt Fluid Delivery SystemSummary page 4…Name: Squirt® Fluid Delivery System Predicate Classification Name: Catheter, Continuous Flush Device Premarket Notification: K981417 Manufacturer: Merit Medical Systems, Inc. The predicate has not been subject… | 1998 |
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 26 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K981417.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 as stated in the FDA summary.
https://510kreport.com/device/K162777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162777: 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/K162777
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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