510(k) · Cleared
ClearedAlphaVac Multipurpose Mechanical Aspiration System F1885
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Nov 24, 2025 as substantially equivalent to K213402 (Inari Medical, 2022) after a 108-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Nov 24, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K183198 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- 5 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 4 generations backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 3 generations backK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
- 2 generations backK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
- 1 generation backK213402 Triever24, Triever20Inari Medical · 2022
- This deviceK252509 AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| −5 | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −4 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −3 | K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020 | — |
| −2 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16… | Inari Medical, Inc. | 2021 | — |
| −1 | K213402 | Triever24, Triever20 | Inari Medical | 2022 | — |
| 0 (this device) | K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K213402 | Triever24, Triever20Summary page 5…(21 CFR § 878.1210, Class II, Pro-Code KRA) Classification Panel: Cardiovascular D. PREDICATE DEVICE 510(k): K213402 Trade Name: Triever24, Triever20 Common/Usual Name: Aspiration Thrombectomy Catheter Classifi… | 2022 |
| † | K240397 | AlphaVac MMA F1885 System (H787253020) | 2024 |
| † | K212392 | Intri24 Sheath | 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 7 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- 7 other devices also cite its predicate K213402.
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 Cannula is indicated for:
• the non-surgical removal of thrombi or emboli from the vasculature
• aspiration and injection of contrast media and other fluids from and into the vasculature
The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.
The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.
The Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of the AlphaVac Cannula/Obturator and other endovascular devices while minimizing blood loss associated with such insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252509: AlphaVac Multipurpose Mechanical Aspiration System F1885.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252509
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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