510(k) · Cleared
ClearedAspiron (TM) Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meril Life Sciences Private Limited · QEZ Aspiration Thrombectomy Catheter
Cleared on Apr 29, 2019 as substantially equivalent to K152335 (Medtronic, Inc., 2015) after a 49-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Apr 29, 2019
- Review
- 49 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010579 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 7 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 6 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 5 generations backK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- 4 generations backK081573 Medtronic Export AP CatheterMedtronic Vascular · 2008
- 3 generations backK120808 Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012
- 2 generations backK130536 Export Advance Aspiration CatheterMedtronic, Inc. · 2013
- 1 generation backK152335 Export Advance Aspiration CatheterMedtronic, Inc. · 2015
- This deviceK190619 Aspiron (TM) Aspiration CatheterMeril Life Sciences Private Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −7 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −6 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −5 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| −4 | K081573 | Medtronic Export AP Catheter | Medtronic Vascular | 2008 | — |
| −3 | K120808 | Export XT Catheter, Export AP Catheter | Medtronic, Inc. | 2012 | — |
| −2 | K130536 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2013 | — |
| −1 | K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015 | — |
| 0 (this device) | K190619 | Aspiron (TM) Aspiration Catheter | Meril Life Sciences Private Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K152335 | Export Advance Aspiration CatheterSummary page 5…assification Name: Embolectomy Catheter (21 CFR 870.5150, Product Code QEZ) Device Class: Class II 5.5 Predicate device: Export Advance™ Aspiration Catheter (K152335) 5.6 Device description: The AspironTM Aspiration Catheter is a dual lumen, rapid exchange catheter consisting of a d… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K152335.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Aspiron(TM) Aspiration Catheter is used for removal of fresh, soft emboli and thrombi from vessels in the coronary
and peripheral vasculature system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190619: Aspiron (TM) Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190619
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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