510(k) · Cleared
ClearedPowered Aventus 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 27, 2026 as substantially equivalent to K253925 (Inquis Medical, 2026) after a 115-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Jul 27, 2026
- Review
- 115 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 deviceK261105 Powered Aventus Thrombectomy System™Inquis 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) | K261105 | Powered 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 Regulation Number: 21 CFR 870.5150 III. PREDICATE DEVICES Predicate Device: Aventus Thrombectomy System (K253925) Reference Device: Symphony Thrombectomy System (K252057) IV. DEVICE DESCRIPTION The Powered Aven… | 2026 |
| † | K252057 | Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System | 2025 |
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 Powered 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 Powered Aventus Thrombectomy System™ is intended for use in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261105 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261105: Powered Aventus Thrombectomy System™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261105
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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