510(k) · Cleared
ClearedClearLumen II Peripheral Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walk Vascular, LLC · QEZ Aspiration Thrombectomy Catheter
Cleared on Feb 21, 2017 as substantially equivalent to K161786 (Walk Vascular, LLC, 2016) after a 112-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Feb 21, 2017
- Review
- 112 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K904788 (1990). 50 ancestors in all, the oldest K873004 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 5 generations between
- 3 generations backK120508 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012
- 2 generations backK140296 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014
- 1 generation backK161786 ClearLumen II Thrombectomy SystemWalk Vascular, LLC · 2016
- This deviceK163051 ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC · 2017
Show all 9 generations
- Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 8 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 7 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 6 generations backK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
- 5 generations backK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
- 4 generations backK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- 3 generations backK120508 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012
- 2 generations backK140296 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014
- 1 generation backK161786 ClearLumen II Thrombectomy SystemWalk Vascular, LLC · 2016
- This deviceK163051 ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −8 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −7 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −6 | K031485 | Rinspiration System | Kerberos Proximal Solutions | 2003 | — |
| −5 | K041291 | Rinspiration System | Kerberos Proximal Solutions, Inc. | 2004 | — |
| −4 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| −3 | K120508 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2012 | — |
| −2 | K140296 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2014 | — |
| −1 | K161786 | ClearLumen II Thrombectomy System | Walk Vascular, LLC | 2016 | — |
| 0 (this device) | K163051 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 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 QEZ? 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 5 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 |
|---|---|---|---|
| * | K161786 | ClearLumen II Thrombectomy SystemSummary page 4…Name: Embolectomy Catheter (21 CFR 870.5150) Product Code: DXE Predicate Device: Walk Vascular ClearLumen II Thrombectomy System (K161786) Device Description: The ClearLumen II Peripheral Thrombectomy System is a multi-lumen device that allows for simultaneous hydro… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 50 ancestors have a recall of any class.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The ClearLumen II Peripheral Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163051: ClearLumen II Peripheral Thrombectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163051
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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