510(k) · Cleared

Recalled · 2010

Fountain Infusion Catheter and Occluding Guide Wire

K974067510(k) TraditionalCleared Feb 27, 1998123-day reviewClass II21 CFR 870.5150Recalls 23

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

Merit Medical Systems, Inc. · QEY Mechanical Thrombolysis Catheter

Cleared on Feb 27, 1998 as substantially equivalent to K961763 (Angiodynamics, Div. E-Z-Em, Inc., 1996) and 1 other predicate after a 123-day review. Its family tree reaches back 1 generation to 1990. 2 of the 104 devices in its family, counting itself, have a Class I recall. 101 later devices descend from it. It has been recalled 23 times.

Decided: Feb 27, 1998
Review: 123 days
Class: Class II
Product code: QEY
Recalls: 23
Predicates: 2

Its longest line of descent runs back 1 generation to K904788 (1990). 2 ancestors in all. 101 later devices descend from it, 6 citing it directly. 2 of the 104 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK904788 Mewissen CatheterBoston Scientific Corp · 1990
This deviceK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998
Descendant · cites it directly · 95 of its ownK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
Descendant · 2 generations on · 75 of its ownK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
Descendant · 3 generations on · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
Descendant · 3 generations on · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
Descendant · 4 generations on · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003

Showing 5 of 101 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 System6 generations on · 2007
K130904 Trellis-8 Peripheral Infusion System6 generations on · 2013

Most influential descendants

Showing 5 of 101 · See all

K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998 · cites it directly95descendants
K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc. · 2002 · 2 generations on75descendants
K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · 3 generations on57descendants
K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · 3 generations on56descendants
K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 4 generations on50descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904788	Mewissen Catheter	Boston Scientific Corp	1990	—
0 (this device)	K974067	Fountain Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	1998	—
+1	K981417	Squirt Fluid Delivery System	Merit Medical Systems, Inc.	1998	—
+2	K013635	Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…	Bacchus Vascular, Inc.	2002	—
+3	K021958	Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…	Bacchus Vascular, Inc.	2002	1
+3	K023514	Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…	Bacchus Vascular, Inc.	2002	1
+4	K030637	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
1998	1	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	1	1
2014	2	0
2016	5	0
2017	1	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 K974067, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K961763	Pulse*Spray Infusion System	Angiodynamics, Div. E-Z-Em, Inc.	1996	3
*	K904788	Mewissen Catheter Summary page 5 …(07/17/96) . Medwissen Infusion Catheter K904788 Medi-Tech…	Boston Scientific Corp	1990	—
*	—	Multi-Sideport Catheter Infusion Set Named without a submission number			—

Also cleared against K961763: 2 other devices →

What descends from it? (101)

See all 101

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

Number	Device	Applicant	Decided	Descendants
K981417	Squirt Fluid Delivery System	Merit Medical Systems, Inc.	1998	95
K991619	FOUNTAIN Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	1999	43
K992231	FOUNTAIN Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	1999	40
K041629	Lysus Infusion System	Ekos Corp.	2004	39
K031485	Rinspiration System	Kerberos Proximal Solutions	2003	19
K193082	Fountain ValveTip Infusion Catheter	Merit Medical Systems, Inc.	2020	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 6, 2010	Not classified	Z-0873-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0876-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0877-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0878-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0881-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0886-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0872-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0875-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0880-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0885-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0874-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0882-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0883-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0884-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0887-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0889-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0894-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0879-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0888-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0890-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0891-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0892-2010	Storage	Infusion catheters may become brittle and break during use.
Jan 6, 2010	Not classified	Z-0893-2010	Storage	Infusion catheters may become brittle and break during use.

The 5 latest of 23 recalls; the web page lists all.

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

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K981417 (Merit Medical Systems, Inc., 1998) has gone furthest, with 95 descendants of its own.
2 other devices also cite its predicate K961763.

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 Fountain Infusion Catheter and Occluding Guide Wire will be used for the infusion of various therapeutic drugs into the peripheral vasculature' of a patient.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K974067 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974067: Fountain Infusion Catheter and Occluding Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974067

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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