510(k) · Cleared
Recalled · 2010Xtract Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumen Biomedical, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Aug 10, 2007 as substantially equivalent to K053372 (Lumen Biomedical, Inc., 2006) after a 66-day review. Its family tree reaches back 5 generations to 2001. 9 later devices descend from it. It has been recalled once.
- Decided
- Aug 10, 2007
- Review
- 66 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010579 (2001). 12 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 4 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 3 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 2 generations backK050139 Modification to: Export CatheterMedtronic Vascular · 2005
- 1 generation backK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
- This deviceK071529 Xtract Catheter SystemLumen Biomedical, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · 2 generations on · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
- Descendant · cites it directly · 1 of its ownK082348 Fibernet Embolic Protection SystemLumen Biomedical, Inc. · 2008 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · cites it directly6descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · cites it directly5descendants
- K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · 2 generations on1descendant
- K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology · 2020 · 2 generations on1descendant
- K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc. · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −4 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −3 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −2 | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
| −1 | K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | 2006 | — |
| 0 (this device) | K071529 | Xtract Catheter System | Lumen Biomedical, Inc. | 2007 | — |
| +1 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| +1 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +2 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +2 | K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical… | Control Medical Technology | 2020 | — |
| +1 | K082348 | Fibernet Embolic Protection System | Lumen Biomedical, Inc. | 2008 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K053372 | Lbi Catheter SystemSummary page 5…embolectomy Catheter, thrombectomy Classification Name: Catheter, embolectomy Predicate(s): LBI Aspiration Catheter (K0533 72) Intended Use: The XtractTM Catheter System is indicated for the removal of fresh, soft… | 2006 |
What descends from it? (9)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2010 | Not classified | Z-0445-2011 | Device Design | Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K080901 (Lumen Biomedical, Inc., 2008) has gone furthest, with 6 descendants of its own.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Xtract® Catheter System is indicated for the removal of fresh, soft emboli and
thrombi from vessels in the arterial system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071529: Xtract Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071529
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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