510(k) · Cleared
ClearedVersus™ Catheter (VS110-9NB)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liquet Medical, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Feb 17, 2026 as substantially equivalent to K241851 (Liquet Medical, Inc., 2024) after a 28-day review. Its family tree reaches back 20 generations to 1990. 1 of the 64 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 17, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K904788 (1990). 63 ancestors in all, the oldest K810124 (1981). No later device cites it as a predicate yet. 1 of the 64 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 16 generations between
- 3 generations backK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- 2 generations backK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- 1 generation backK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
- This deviceK260149 Versus™ Catheter (VS110-9NB)Liquet Medical, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 19 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 18 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 17 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 16 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 15 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 14 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 13 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 12 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 11 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 10 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 9 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 8 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 7 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 6 generations backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- 5 generations backK073166 Endowave Infusion SystemEkos Corp. · 2008
- 4 generations backK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- 3 generations backK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- 2 generations backK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- 1 generation backK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
- This deviceK260149 Versus™ Catheter (VS110-9NB)Liquet Medical, Inc. · 2026
Class I recalls in this family
- K160084 Swan Ganz Catheters2 generations back · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −19 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −18 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −17 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −16 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −15 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −14 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −13 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −12 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −11 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −10 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −9 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −8 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| −7 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| −6 | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| −5 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| −4 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
| −3 | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | 5 |
| −2 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| −1 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024 | — |
| 0 (this device) | K260149 | Versus™ Catheter (VS110-9NB) | Liquet Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 1 |
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.
1 device in this family has 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
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 |
|---|---|---|---|
| * | K241851 | Versus™ Catheter (VS110-8B)Summary page 5…Regulation Number: 870.5150 Classification Codes: QEY Associated Product Codes: KRA, DQO III. Predicate Devices Versus™ Catheter VS110-8B (K241851) IV. Device Description The Versus™ Pulmonary Artery Catheter is a dual-tip, infusion catheter. Two lumens acce… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 16 of the 63 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Versus™ Catheter is indicated for:
The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.
The assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260149 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260149: Versus™ Catheter (VS110-9NB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260149
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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