510(k) · Cleared
ClearedMerit Embolectomy Catheter Model ASAP100
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 Mar 11, 2011 as substantially equivalent to K063371 (Vascular Solutions, Inc., 2006) after a 375-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it.
- Decided
- Mar 11, 2011
- Review
- 375 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052232 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK052232 Vascular Solutions Pronto V3 Extraction CatheterVascular Solutions, Inc. · 2005
- 1 generation backK063371 Pronto V3 Extraction Catheter, Model 5003Vascular Solutions, Inc. · 2006
- This deviceK100569 Merit Embolectomy Catheter Model ASAP100Merit Medical Systems, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK132155 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052232 | Vascular Solutions Pronto V3 Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| −1 | K063371 | Pronto V3 Extraction Catheter, Model 5003 | Vascular Solutions, Inc. | 2006 | — |
| 0 (this device) | K100569 | Merit Embolectomy Catheter Model ASAP100 | Merit Medical Systems, Inc. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K063371 | Pronto V3 Extraction Catheter, Model 5003Summary page 5…ame: Catheter, Embolectomy Predicate Device Trade Name: Pronto V3 Extraction Catheter, Model 5003 Classification Name: Catheter, Embolectomy Premarket Notification: K063371 Manufacturer: Vascular Solutions, Inc. Classification Class Il per 21 CFR § 870.5150 Product Code: DXE Review Branch: Divisi… | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132155 (Merit Medical Systems, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K063371.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Embolectomy Catheter is intended for use 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/K100569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100569: Merit Embolectomy Catheter Model ASAP100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100569
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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