510(k) · Cleared
ClearedAlphaVac MMA F1885 System (H787253020)
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 Apr 1, 2024 as substantially equivalent to K180466 (Inari Medical, Inc., 2018) after a 52-day review. Its family tree reaches back 5 generations to 1983. 3 of the 19 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 1, 2024
- Review
- 52 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K832023 (1983). 18 ancestors in all. No later device cites it as a predicate yet. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 4 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 3 generations backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- 2 generations backK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- 1 generation backK180466 FlowTriever Retrieval/Aspiration SystemInari Medical, Inc. · 2018
- This deviceK240397 AlphaVac MMA F1885 System (H787253020)AngioDynamics, Inc. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −4 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −3 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| −2 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| −1 | K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | 2018 | — |
| 0 (this device) | K240397 | AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 1 |
| 1998 | 4 | 1 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K180466 | FlowTriever Retrieval/Aspiration SystemSummary page 5…r (21 CFR § 878.5150, Class II, Pro-Code QEZ) Classification Panel: Cardiovascular D. PREDICATE DEVICE 510(k): K180466 Trade Name: FlowTriever Retrieval/Aspiration System Common/Usual Name: Embolectomy catheter Class… | 2018 |
| † | K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 41 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- 5 of the 18 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K180466.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 of contrast media and other fluids from 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240397: AlphaVac MMA F1885 System (H787253020).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240397
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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