510(k) · Cleared
ClearedMerit 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 7, 2013 as substantially equivalent to K100569 (Merit Medical Systems, Inc., 2011) after a 118-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Nov 7, 2013
- Review
- 118 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052232 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK052232 Vascular Solutions Pronto V3 Extraction CatheterVascular Solutions, Inc. · 2005
- 2 generations backK063371 Pronto V3 Extraction Catheter, Model 5003Vascular Solutions, Inc. · 2006
- 1 generation backK100569 Merit Embolectomy Catheter Model ASAP100Merit Medical Systems, Inc. · 2011
- This deviceK132155 Merit ASAPLP Aspiration CatheterMerit Medical Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK212199 ASAP Aspiration Catheter, ASAPLP Aspiration CatheterMerit Medical Systems, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212199ASAP Aspiration Catheter, ASAPLP Aspiration CatheterMerit Medical Systems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052232 | Vascular Solutions Pronto V3 Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| −2 | K063371 | Pronto V3 Extraction Catheter, Model 5003 | Vascular Solutions, Inc. | 2006 | — |
| −1 | K100569 | Merit Embolectomy Catheter Model ASAP100 | Merit Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K132155 | Merit ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2013 | — |
| +1 | K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K100569 | Merit Embolectomy Catheter Model ASAP100Summary page 5…Trade Name: ASAP® Aspiration Catheter Predicate Classification Name: Embolectomy Catheter Device Premarket Notification: K100569 Manufacturer: Merit Medical Systems, Inc. Class II 21… | 2011 |
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 |
|---|---|---|---|
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | 2021 | 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 8 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K212199 (Merit Medical Systems, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 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. 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 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 as stated in the FDA summary.
https://510kreport.com/device/K132155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132155: Merit 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/K132155
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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