510(k) · Cleared
ClearedAventus Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inquis Medical · QEZ Aspiration Thrombectomy Catheter
Cleared on Jul 15, 2026 as substantially equivalent to K253925 (Inquis Medical, 2026) after a 28-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Jul 15, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K951592 (1996). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK951592 Betatrans I and IIDuxbury Scientific, Inc. · 1996
- 5 generations backK022489 Summit Medical LTD Celltrans Postoperative Autotransfusion System…Summit Medical, Ltd. · 2002
- 4 generations backK024097 Summit Medical LTD Celltrans Postoperative Autotransfusion Set…Summit Medical, Ltd. · 2003
- 3 generations backK210176 FlowSaver Blood FilterInari Medical · 2021
- 2 generations backK240426 Aventus Clot Management SystemInquis Medical · 2024
- 1 generation backK253925 Aventus Thrombectomy SystemInquis Medical · 2026
- This deviceK262030 Aventus Thrombectomy SystemInquis Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951592 | Betatrans I and II | Duxbury Scientific, Inc. | 1996 | — |
| −5 | K022489 | Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models… | Summit Medical, Ltd. | 2002 | — |
| −4 | K024097 | Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models… | Summit Medical, Ltd. | 2003 | — |
| −3 | K210176 | FlowSaver Blood Filter | Inari Medical | 2021 | — |
| −2 | K240426 | Aventus Clot Management System | Inquis Medical | 2024 | — |
| −1 | K253925 | Aventus Thrombectomy System | Inquis Medical | 2026 | — |
| 0 (this device) | K262030 | Aventus Thrombectomy System | Inquis Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K253925 | Aventus Thrombectomy SystemSummary page 5…QEZ, KRA, CAC Regulation Number: 21 CFR 870.5150 III. PREDICATE DEVICES Predicate Device: Aventus Thrombectomy System (K253925) Reference Device: Aventus Clot Management System (K240426) IV. DEVICE DESCRIPTION The Aventus… | 2026 |
| † | K240426 | Aventus Clot Management System | 2024 |
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 30 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K253925.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Aventus Thrombectomy System is indicated for:
• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262030: Aventus Thrombectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262030
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026