510(k) · Cleared
ClearedVascular Solutions Pronto V3 Extraction Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Sep 28, 2005 after a 42-day review. The FDA summary names its predicate without a number. 1 of the 34 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.
- Decided
- Sep 28, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 4 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- This deviceK052232 Vascular Solutions Pronto V3 Extraction CatheterVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 27 of its ownK063371 Pronto V3 Extraction Catheter, Model 5003Vascular Solutions, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K101354 Fetch 2 Aspiration Catheter Model 109400-0014 generations on · 2011
Most influential descendants
Showing 5 of 33 · See all- K063371Pronto V3 Extraction Catheter, Model 5003Vascular Solutions, Inc. · 2006 · cites it directly27descendants
- K071727QXT Extraction CatheterVascular Solutions, Inc. · 2007 · cites it directly12descendants
- K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007 · cites it directly11descendants
- K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc. · 2009 · 2 generations on10descendants
- K053372Lbi Catheter SystemLumen Biomedical, Inc. · 2006 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052232 | Vascular Solutions Pronto V3 Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| +1 | K063371 | Pronto V3 Extraction Catheter, Model 5003 | Vascular Solutions, Inc. | 2006 | — |
| +1 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| +1 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| +2 | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| +1 | K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 1 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 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? (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 |
|---|---|---|---|
| * | — | Vascular Solutions, Inc. Pronto Extraction Catheter Named without a submission number | |
| * | — | Medtronic Export™ Aspiration Catheter Named without a submission number |
What descends from it? (33)
See all 334 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K063371 (Vascular Solutions, Inc., 2006) has gone furthest, with 27 descendants of its own.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial systems.
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/K052232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052232: Vascular Solutions Pronto V3 Extraction Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052232
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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