510(k) · Cleared
ClearedASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Nov 3, 2021 as substantially equivalent to K100569 (Merit Medical Systems, Inc., 2011) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Nov 3, 2021
- Review
- 112 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K052232 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK052232 Vascular Solutions Pronto V3 Extraction CatheterVascular Solutions, Inc. · 2005
- 3 generations backK063371 Pronto V3 Extraction Catheter, Model 5003Vascular Solutions, Inc. · 2006
- 2 generations backK100569 Merit Embolectomy Catheter Model ASAP100Merit Medical Systems, Inc. · 2011
- 1 generation backK132155 Merit ASAPLP Aspiration CatheterMerit Medical Systems, Inc. · 2013
- This deviceK212199 ASAP Aspiration Catheter, ASAPLP Aspiration CatheterMerit Medical Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K052232 | Vascular Solutions Pronto V3 Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| −3 | K063371 | Pronto V3 Extraction Catheter, Model 5003 | Vascular Solutions, Inc. | 2006 | — |
| −2 | K100569 | Merit Embolectomy Catheter Model ASAP100 | Merit Medical Systems, Inc. | 2011 | — |
| −1 | K132155 | Merit ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K100569 | Merit Embolectomy Catheter Model ASAP100Summary page 4…Trade Name: ASAP® Aspiration Catheter Classification Name: Embolectomy Catheter Primary Premarket Notification: K100569 Predicate Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject to a… | 2011 |
| * | K132155 | Merit ASAPLP Aspiration CatheterSummary page 4…Trade Name: ASAPLP™ Aspiration Catheter Secondary Classification Name: Embolectomy Catheter Predicate Premarket Notification: K132155 Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject to a… | 2013 |
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 16 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K100569.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Merit ASAP® Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
The Merit ASAPLP™ Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral 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/K212199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212199: ASAP Aspiration Catheter, ASAPLP 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/K212199
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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