510(k) · Cleared
Recalled · 2010Quickcat Extraction Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corp. · QEZ Aspiration Thrombectomy Catheter
Cleared on Mar 9, 2006 as substantially equivalent to K050276 (Invatec Innovative Technologies, S.R.L., 2005) and 2 other predicates after a 56-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010579 (2001). 10 ancestors in all. 2 later devices descend from it, 1 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 deviceK060092 Quickcat Extraction CatheterKensey Nash Corp. · 2006
- Descendant · cites it directly · 1 of its ownK073519 Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK091703 HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130…Concentric Medical, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView 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) | K060092 | Quickcat Extraction Catheter | Kensey Nash Corp. | 2006 | — |
| +1 | K073519 | Quickcat Extraction Catheter, Model 60090-01 | Kensey Nash Corp. | 2008 | 1 |
| +2 | K091703 | HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131 | Concentric Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K050276 | Diver C.E. CatheterSummary page 1…y Class: Class II Device Product Code: DXE Predicate Device: Invatec Innovative Technologies' Diver C.E. Catheter (K050276), Medtronic Inc.'s Export Catheter (K040869), and Vascular Solution's Pro… | 2005 |
| * | K040869 | Export CatheterSummary page 1…vice: Invatec Innovative Technologies' Diver C.E. Catheter (K050276), Medtronic Inc.'s Export Catheter (K040869), and Vascular Solution's Pronto Extraction Catheter (K032763) Date Prepared: January 11… | 2004 |
| * | K032763 | Vascular Solutions Pronto Extraction CatheterSummary page 1…theter (K050276), Medtronic Inc.'s Export Catheter (K040869), and Vascular Solution's Pronto Extraction Catheter (K032763) Date Prepared: January 11, 2006 Description of Device The QuickCatTM Extraction Catheter is a single use, disposabl… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073519 | Quickcat Extraction Catheter, Model 60090-01 | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2010 | Not classified | Z-2190-2010 | Process control | Guidewire lumen may be occluded, preventing guidewire insertion into the catheter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K073519 (Kensey Nash Corp., 2008) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K050276.
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 QuickCatTM Extraction Catheter 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/K060092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060092: Quickcat Extraction Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060092
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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