510(k) · Cleared
ClearedModification to: Export Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · QEZ Aspiration Thrombectomy Catheter
Cleared on Mar 22, 2005 as substantially equivalent to K040869 (Medtronic Vascular, 2004) after a 60-day review. Its family tree reaches back 3 generations to 2001. 14 later devices descend from it.
- Decided
- Mar 22, 2005
- Review
- 60 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010579 (2001). 7 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 2 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 1 generation backK040869 Export CatheterMedtronic Vascular · 2004
- This deviceK050139 Modification to: Export CatheterMedtronic Vascular · 2005
- Descendant · cites it directly · 10 of its ownK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK071529 Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · cites it directly · 2 of its ownK052523 Proxis SystemVelocimed, Inc. · 2006
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K053372Lbi Catheter SystemLumen Biomedical, Inc. · 2006 · cites it directly10descendants
- K071529Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · 2 generations on9descendants
- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 3 generations on6descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 3 generations on5descendants
- K052523Proxis SystemVelocimed, Inc. · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −2 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −1 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| 0 (this device) | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
| +1 | K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | 2006 | — |
| +2 | K071529 | Xtract Catheter System | Lumen Biomedical, Inc. | 2007 | 1 |
| +3 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| +3 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +1 | K052523 | Proxis System | Velocimed, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K040869 | Export CatheterSummary page 5…(978) 777-0042 Classification Name: Embolectomy Catheter (21 CFR Part 870.5150) Proprietary Name: Export Catheter Name of Predicate Devices: Medtronic Export Catheter (K040869) Description: The Export Catheter is a dual lumen catheter for use as a general embolectomy catheter. The main (continuous) lume… | 2004 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K053372 (Lumen Biomedical, Inc., 2006) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K040869.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Export Aspiration Catheter is indicated for:
Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050139: Modification to: Export Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050139
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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