510(k) · Cleared

Recalled · Class II · 2014

Pulse*Spray Infusion System

K961763510(k) TraditionalCleared Jul 17, 199671-day reviewClass II21 CFR 870.5150Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Angiodynamics, Div. E-Z-Em, Inc. · QEY Mechanical Thrombolysis Catheter

Cleared on Jul 17, 1996 after a 71-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 105 devices in its family, counting itself, have a Class I recall. 104 later devices descend from it. It has been recalled 3 times.

Decided: Jul 17, 1996
Review: 71 days
Class: Class II
Product code: QEY
Recalls: 3
Predicates: 0

104 later devices descend from it, 3 citing it directly. 2 of the 105 devices in this family, counting this one, have a Class I recall.

This deviceK961763 Pulse*Spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc. · 1996
Descendant · cites it directly · 101 of its ownK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
Descendant · 2 generations on · 95 of its ownK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
Descendant · 3 generations on · 75 of its ownK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
Descendant · 4 generations on · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
Descendant · 4 generations on · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled

Showing 5 of 104 descendants. See all descendants

Descendants cleared per year

1998high 10 (2005) · low 0 (2000)2026

Class I recalls in this family

K071664 Trellis-6 Peripheral Infusion System7 generations on · 2007
K130904 Trellis-8 Peripheral Infusion System7 generations on · 2013

Most influential descendants

Showing 5 of 104 · See all

K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · cites it directly101descendants
K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998 · 2 generations on95descendants
K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc. · 2002 · 3 generations on75descendants
K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · 4 generations on57descendants
K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · 4 generations on56descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K961763	Pulse*Spray Infusion System	Angiodynamics, Div. E-Z-Em, Inc.	1996	—
+1	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	—
+3	K013635	Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…	Bacchus Vascular, Inc.	2002	—
+4	K021958	Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…	Bacchus Vascular, Inc.	2002	1
+4	K023514	Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…	Bacchus Vascular, Inc.	2002	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	2	0
2002	3	0
2003	5	0
2004	7	0
2005	10	0
2006	7	0
2007	7	1
2008	8	0
2011	1	0
2012	2	0
2013	2	1
2014	2	0
2016	5	0
2017	2	0
2018	3	0
2019	5	0
2020	7	0
2021	2	0
2022	3	0
2023	4	0
2024	5	0
2025	3	0
2026	7	0

FIG. 1 — Lineage of K961763, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (104)

See all 104

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K974067	Fountain Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	1998	101
K163356	Pulse* Spray Infusion System, Uni*Fuse Infusion System	AngioDynamics, Inc.	2017	0
K123235	Equaflow Multivalve Infusion Catheter	Cook Incorporated	2013	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 6, 2014	Class II	Z-2261-2014	Component design/selection	AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
Aug 6, 2014	Class II	Z-2260-2014	Component design/selection	AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
Aug 6, 2014	Class II	Z-2262-2014	Component design/selection	AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

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.

K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 7 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K974067 (Merit Medical Systems, Inc., 1998) has gone furthest, with 101 descendants of its own.

How does its category compare?

All QEY devices

QEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEY

1in 2024

2007high 5 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEY

62in 2021

2007high 158 (2020) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEY

1in 2023

2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QEY

5in 2025

2007high 5 (2025) · low 0 (2007)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, PROTM Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K961763 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961763: Pulse*Spray Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961763

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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