510(k) · Cleared
Recalled · Class II · 2023Pulse* Spray Infusion System, Uni*Fuse Infusion System
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 May 30, 2017 as substantially equivalent to K961763 (Angiodynamics, Div. E-Z-Em, Inc., 1996) after a 181-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.
- Decided
- May 30, 2017
- Review
- 181 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961763 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961763 Pulse*Spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc. · 1996 · Recalled
- This deviceK163356 Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961763 | Pulse*Spray Infusion System | Angiodynamics, Div. E-Z-Em, Inc. | 1996 | 3 |
| 0 (this device) | K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | AngioDynamics, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K961763 | Pulse*Spray Infusion SystemSummary page 5…Predicate Device: Trade Name: AngioDynamics Pulse*Spray and Uni*Fuse Infusion Systems 510(k) Reference: K961763 Common Name: Infusion Catheter Regulation Number; 21 CFR 870.1210 Regulation Name: Continuous… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2023 | Class II | Z-1010-2024 | Process control | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K961763.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
The Uni*Fuse Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163356 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163356: Pulse* Spray Infusion System, Uni*Fuse Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163356
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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