510(k) · Cleared
Recalled · 2009Vascular Solutions Pronto Short 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 Aug 8, 2005 after a 90-day review. The FDA summary names its predicate without a number. 34 later devices descend from it. It has been recalled once.
- Decided
- Aug 8, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 0
34 later devices descend from it, 4 citing it directly.
- This deviceK051193 Vascular Solutions Pronto Short Extraction CatheterVascular Solutions, Inc. · 2005
- 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 ownK070403 Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK071529 Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- 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
- K070403Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007 · cites it directly10descendants
- K053372Lbi Catheter SystemLumen Biomedical, Inc. · 2006 · cites it directly10descendants
- K071529Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051193 | Vascular Solutions Pronto Short Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| +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 | K070403 | Pronto .035 Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| +1 | K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | 2006 | — |
| +2 | K071529 | Xtract Catheter System | Lumen Biomedical, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | — | Cordis 7Fr Hydrolyser Thrombectomy Catheter Named without a submission number | |
| * | — | XTD Thrombectomy Catheter Named without a submission number | |
| * | — | Medtronic Export Aspiration Catheter Named without a submission number | |
| * | — | Vascular Solutions, Inc. Pronto Extraction Catheter Named without a submission number |
What descends from it? (34)
See all 344 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2009 | Not classified | Z-0547-2010 | Process control | It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072810 (Vascular Solutions, Inc., 2007) has gone furthest, with 11 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™ Short Extraction Catheter is indicated for:
* the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system.
* the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.
The Pronto™ Short Extraction Catheter is indicated for:
* the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system.
* the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.
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/K051193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051193: Vascular Solutions Pronto Short 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/K051193
Report an extraction error
Are you the manufacturer?
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