510(k) · Cleared
Recalled · Class II · 2023FOUNTAIN Infusion Catheter and Occluding Guide Wire
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 23, 1999 as substantially equivalent to K974067 (Merit Medical Systems, Inc., 1998) and 1 other predicate after a 21-day review. Its family tree reaches back 3 generations to 1990. 40 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904788 (1990). 4 ancestors in all. 40 later devices descend from it, 1 citing it directly.
- 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 backK991619 FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1999
- This deviceK992231 FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1999
- Descendant · cites it directly · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004
- Descendant · 2 generations on · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- Descendant · 3 generations on · 35 of its ownK051319 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 4 generations on · 34 of its ownK052071 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 5 generations on · 27 of its ownK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K041629Lysus Infusion SystemEkos Corp. · 2004 · cites it directly39descendants
- K042456Lysus Infusion SystemEkos Corp. · 2004 · 2 generations on38descendants
- K051319Lysus Infusion SystemEkos Corp. · 2005 · 3 generations on35descendants
- K052071Lysus Infusion SystemEkos Corp. · 2005 · 4 generations on34descendants
- K060422Lysus Infusion SystemEkos Corp. · 2006 · 5 generations on27descendants
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 | K991619 | FOUNTAIN Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K992231 | FOUNTAIN Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1999 | — |
| +1 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| +2 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| +3 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +4 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +5 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
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 |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (2)
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 WireSummary page 5…Trade Name: FOUNTAIN Infusion System Classification (if known): Intravascular Catheter Predicate Device: 5 French FOUNTAINn Infusion Catheter and Occluding Guide Wire (K974067) & K991619 Fountain Infusion System Device Description: 10 AT FEXIA T ATYNT T TATOTTT FOONHNT 00T TNO VYI 070T NNATW RR/7T /71… | 1998 |
| * | K991619 | FOUNTAIN Infusion Catheter and Occluding Guide WireSummary page 5…: FOUNTAIN Infusion System Classification (if known): Intravascular Catheter Predicate Device: 5 French FOUNTAINn Infusion Catheter and Occluding Guide Wire (K974067) & K991619 Fountain Infusion System Device Description: 10 AT FEXIA T ATYNT T TATOTTT FOONHNT 00T TNO VYI 070T NNATW RR/7T /71N === Page… | 1999 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041629 | Lysus Infusion System | 2004 | 39 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2023 | Class II | Z-0629-2024 | Package design/selection | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| May 14, 2008 | Not classified | Z-2107-2008 | Packaging process control | Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K041629 (Ekos Corp., 2004) has gone furthest, with 39 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 FOUNTAIN™ Infusion Catheter and Occluding Guide Wire is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient
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/K992231 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992231: FOUNTAIN Infusion Catheter and Occluding Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992231
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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