510(k) · Cleared
ClearedLiberant™ RX Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Interventional Vascular, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Apr 23, 2026 as substantially equivalent to K152335 (Medtronic, Inc., 2015) and 1 other predicate after a 157-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Apr 23, 2026
- Review
- 157 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K010579 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 7 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 6 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 5 generations backK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- 4 generations backK081573 Medtronic Export AP CatheterMedtronic Vascular · 2008
- 3 generations backK120808 Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012
- 2 generations backK130536 Export Advance Aspiration CatheterMedtronic, Inc. · 2013
- 1 generation backK152335 Export Advance Aspiration CatheterMedtronic, Inc. · 2015
- This deviceK253589 Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −7 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −6 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −5 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| −4 | K081573 | Medtronic Export AP Catheter | Medtronic Vascular | 2008 | — |
| −3 | K120808 | Export XT Catheter, Export AP Catheter | Medtronic, Inc. | 2012 | — |
| −2 | K130536 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2013 | — |
| −1 | K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015 | — |
| 0 (this device) | K253589 | Liberant™ RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K152335 | Export Advance Aspiration CatheterSummary page 5…FR 870.5150, 21 CFR 870.1210 Product Code: QEZ, KRA Predicate Device Name: Export Advance™ Aspiration Catheter, cleared under K152335 on 18th September 2015 and K130536 on 16th July 2013 Reference Device Name: Liberant Thrombectomy… | 2015 |
| * | K130536 | Export Advance Aspiration CatheterSummary page 5…RA Predicate Device Name: Export Advance™ Aspiration Catheter, cleared under K152335 on 18th September 2015 and K130536 on 16th July 2013 Reference Device Name: Liberant Thrombectomy System, cleared under K250787 on 11… | 2013 |
| † | K250787 | Liberant 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 25 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K152335.
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 Liberant™ RX aspiration catheter is indicated for the following:
• Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system
• To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253589: Liberant™ RX Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253589
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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