510(k) · Cleared
ClearedAspire RX-LP6 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 Nov 26, 2013 as substantially equivalent to K121301 (Kaneka Pharma America, LLC, 2012) and 2 other predicates after a 151-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Nov 26, 2013
- Review
- 151 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010579 (2001). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 3 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 2 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 1 generation backK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- This deviceK131998 Aspire RX-LP6 Aspiration CatheterControl Medical Technology, LLC · 2013
- Descendant · cites it directly · 0 of its ownK200629 Aspire Mechanical Aspirator GControl Medical Technology · 2020
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −4 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −3 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −2 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −1 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| 0 (this device) | K131998 | Aspire RX-LP6 Aspiration Catheter | Control Medical Technology, LLC | 2013 | — |
| +1 | K200629 | Aspire Mechanical Aspirator G | Control Medical Technology | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K121301 | Xpressway RX Catheter (6F LD-Verison)Summary page 5…tions Pronto Extraction Catheters, Lumen – Volcano Xtract Aspiration Catheters, and other predicate devices. Trade Names: Xpress-Way RX Catheter K121301 July 30, 2012 Export XT Aspiration Catheters K061958 September 5, 2006… | 2012 |
| * | K061958 | Medtronic Export XT CatheterSummary page 5…redicate devices. Trade Names: Xpress-Way RX Catheter K121301 July 30, 2012 Export XT Aspiration Catheters K061958 September 5, 2006 Pronto V3 Aspiration Catheter K063371 Mar 30, 2009 Common Name:… | 2006 |
| * | K063371 | Pronto V3 Extraction Catheter, Model 5003Summary page 5…, 2012 Export XT Aspiration Catheters K061958 September 5, 2006 Pronto V3 Aspiration Catheter K063371 Mar 30, 2009 Common Name: Embolectomy or aspiration catheter and piston syringe Classification Na… | 2006 |
| * | — | Lumen – Volcano Xtract Aspiration Catheters Named without a submission number |
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 |
|---|---|---|---|
| K200629 | Aspire Mechanical Aspirator G | 2020 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K200629 (Control Medical Technology, 2020) has gone furthest, with 0 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. 2013, 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 RX-LP6 Aspiration Catheter and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131998: Aspire RX-LP6 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/K131998
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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