510(k) · Cleared
ClearedModification to Fetch Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Possis Medical, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Sep 26, 2008 as substantially equivalent to K062172 (Possis Medical, Inc., 2006) and 1 other predicate after a 74-day review. Its family tree reaches back 4 generations to 2003. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 26, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K032763 (2003). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK032763 Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2003 · Recalled
- 3 generations backK042937 Modification to Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2005
- 2 generations backK062172 Fetch Aspiration CatheterPossis Medical, Inc. · 2006
- 1 generation backK070363 Fetch Aspiration CatheterPossis Medical, Inc. · 2007
- This deviceK081989 Modification to Fetch Aspiration CatheterPossis Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK101354 Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · Recalled (Class I)
Class I recalls in this family
- K101354 Fetch 2 Aspiration Catheter Model 109400-001cites it directly · 2011
Most influential descendants
Showing 1 of 1 · See all- K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032763 | Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2003 | 1 |
| −3 | K042937 | Modification to Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| −2 | K062172 | Fetch Aspiration Catheter | Possis Medical, Inc. | 2006 | — |
| −1 | K070363 | Fetch Aspiration Catheter | Possis Medical, Inc. | 2007 | — |
| 0 (this device) | K081989 | Modification to Fetch Aspiration Catheter | Possis Medical, Inc. | 2008 | — |
| +1 | K101354 | Fetch 2 Aspiration Catheter Model 109400-001 | Medrad Interventional/Possis | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K062172 | Fetch Aspiration CatheterSummary page 5…tomy Device/ Classification Product Code: DXE and Code: Class 11/21 CFR 870.5150 Cardiovascular Predicate Device: The Fetch Aspiration Catheter - K062172 and K070363 Possis Medical, Inc. 9055 Evergreen Boulevard N.W.… | 2006 |
| * | K070363 | Fetch Aspiration CatheterSummary page 5…Classification Product Code: DXE and Code: Class 11/21 CFR 870.5150 Cardiovascular Predicate Device: The Fetch Aspiration Catheter - K062172 and K070363 Possis Medical, Inc. 9055 Evergreen Boulevard N.W. Min… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101354 | Fetch 2 Aspiration Catheter Model 109400-001 Class I | 2011 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 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 1.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K101354 (Medrad Interventional/Possis, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062172.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081989: Modification to Fetch Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081989
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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