510(k) · Cleared
ClearedAspire Max Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Control Medical Technology, LLC · QEZ Aspiration Thrombectomy Catheter
Cleared on Feb 22, 2012 as substantially equivalent to K061958 (Medtronic Vascular, 2006) and 4 other predicates after a 63-day review. Its family tree reaches back 8 generations to 1990. 3 of the 78 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Feb 22, 2012
- Review
- 63 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K904788 (1990). 72 ancestors in all, the oldest K832023 (1983). 5 later devices descend from it, 3 citing it directly. 3 of the 78 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 7 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 6 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 5 generations backK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
- 4 generations backK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
- 3 generations backK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- 2 generations backK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- 1 generation backK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- This deviceK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · cites it directly · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
- Descendant · 2 generations on · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250013 VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific · 2025
- Descendant · cites it directly · 0 of its ownK200629 Aspire Mechanical Aspirator GControl Medical Technology · 2020
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · cites it directly1descendant
- K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology · 2020 · cites it directly1descendant
- K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026 · 2 generations on0descendants
- K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific · 2025 · 2 generations on0descendants
- K200629Aspire Mechanical Aspirator GControl Medical Technology · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −7 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −6 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −5 | K031485 | Rinspiration System | Kerberos Proximal Solutions | 2003 | — |
| −4 | K041291 | Rinspiration System | Kerberos Proximal Solutions, Inc. | 2004 | — |
| −3 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| −2 | K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006 | — |
| −1 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| 0 (this device) | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +1 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +1 | K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical… | Control Medical Technology | 2020 | — |
| +2 | K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026 | — |
| +2 | K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S… | Control Medical Technology, Inc. / Dba Ventiv Scientific | 2025 | — |
| +1 | K200629 | Aspire Mechanical Aspirator G | Control Medical Technology | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 1 |
| 1998 | 8 | 1 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 1 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have 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? (5)
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 |
|---|---|---|---|
| * | K061958 | Medtronic Export XT Catheter | 2006 |
| * | K051193 | Vascular Solutions Pronto Short Extraction CatheterSummary page 5…Volcano Xtract Aspiration Catheters, and other predicate devices. Trade Names: Export XT Aspiration Catheters KO61958 September 5, 2006 Pronto Short Aspiration Catheter K051193 August 8, 2005 Pronto V3 Aspiration Catheter K063371 Mar 30, 2009 Xtract Aspiration Catheters KO71529 August 10, 2007 Xtract Aspi… | 2005 |
| * | K063371 | Pronto V3 Extraction Catheter, Model 5003Summary page 5…cate devices. Trade Names: Export XT Aspiration Catheters KO61958 September 5, 2006 Pronto Short Aspiration Catheter K051193 August 8, 2005 Pronto V3 Aspiration Catheter K063371 Mar 30, 2009 Xtract Aspiration Catheters KO71529 August 10, 2007 Xtract Aspiration Catheter KO80901 October 2, 2008 Common Name:… | 2006 |
| * | K071529 | Xtract Catheter System | 2007 |
| * | K080901 | Lbi Embolectomy System | 2008 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 14 of the 72 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K220780 (2mg, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K061958.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
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/K113757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113757: Aspire Max 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/K113757
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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