510(k) · Cleared
ClearedVesalio Peripheral System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesalio, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Oct 24, 2025 as substantially equivalent to K193197 (Volcano Atheromed, Inc., 2020) after a 179-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Oct 24, 2025
- Review
- 179 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K003410 (2001). 15 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 13 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 9 generations between
- 3 generations backK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- 2 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 1 generation backK193197 QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc. · 2020
- This deviceK251312 Vesalio Peripheral SystemVesalio, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 12 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 11 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 10 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 9 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 8 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 7 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 6 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 5 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 4 generations backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- 3 generations backK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- 2 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 1 generation backK193197 QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc. · 2020
- This deviceK251312 Vesalio Peripheral SystemVesalio, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −12 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −11 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −10 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −9 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −8 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −7 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −6 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −5 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| −4 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| −3 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -… | Penumbra, Inc. | 2018 | — |
| −2 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | 2018 | — |
| −1 | K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | 2020 | — |
| 0 (this device) | K251312 | Vesalio Peripheral System | Vesalio, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K193197 | QuickClear Mechanical Thrombectomy SystemSummary page 5…bolectomy Catheter (21 CFR 870.5150) Regulatory Class: II Product Code: QEZ, KRA III. PREDICATE DEVICE Primary Predicate: QuickClear Mechanical Thrombectomy System, K193197 Reference Device: JETi AIO Peripheral Thrombectomy System, K213565 The predicate and reference devices have not been subject to a… | 2020 |
| † | K213565 | JETi AIO Peripheral Thrombectomy System | 2022 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K193197.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Vesalio Peripheral Catheter is intended for use in the peripheral arterial vasculature for:
• the removal of fresh, soft emboli and thrombi
• infusion of diagnostic agents, such as contrast media
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251312: Vesalio Peripheral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251312
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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