510(k) · Cleared
ClearedAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
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 4, 2022 as substantially equivalent to K211081 (AngioDynamics, Inc., 2021) after a 172-day review. Its family tree reaches back 7 generations to 1983. 3 of the 21 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 4, 2022
- Review
- 172 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K832023 (1983). 20 ancestors in all. No later device cites it as a predicate yet. 3 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 6 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 5 generations backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- 4 generations backK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- 3 generations backK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
- 2 generations backK173672 FlowTriever Retrieval/Aspiration System, Aspiration Guide CatheterInari Medical · 2018
- 1 generation backK211081 AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemAngioDynamics, Inc. · 2021
- This deviceK213388 AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemAngioDynamics, Inc. · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −6 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −5 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| −4 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| −3 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction… | Inari Medical | 2016 | — |
| −2 | K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter | Inari Medical | 2018 | — |
| −1 | K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | AngioDynamics, Inc. | 2021 | — |
| 0 (this device) | K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemSummary page 4…(21 CFR § 878.5150, Class II, Pro-Code QEZ) Classification Panel: Cardiovascular D. PREDICATE DEVICE 510(k): K211081 Trade Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) System Common/Usual Name: Aspirati… | 2021 |
| † | K212386 | AngioVac F18 85 | 2021 |
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 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 39 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 20 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 venous vasculature.
* aspiration of contrast media and other fluids from venous vasculature.
The Cannula is intended for use in the venous system.
The Handle is indicated as a vacuum source for the AlphaVac MMA System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213388: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213388
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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