510(k) · Cleared
ClearedMerlin Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mivi Neurovascular, Inc. · DXE Catheter, Embolectomy
Cleared on Jan 27, 2022 as substantially equivalent to K161523 (Penumbra, Inc., 2016) after a 56-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Jan 27, 2022
- Review
- 56 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003410 (2001). 12 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 2 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 1 generation backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- This deviceK213771 Merlin Aspiration SystemMivi Neurovascular, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 9 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 8 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 7 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 6 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 5 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 4 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 3 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 2 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 1 generation backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- This deviceK213771 Merlin Aspiration SystemMivi Neurovascular, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −9 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −8 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −7 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −6 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −5 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −4 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −3 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −2 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| −1 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| 0 (this device) | K213771 | Merlin Aspiration System | Mivi Neurovascular, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · 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 |
|---|---|---|---|
| * | K161523 | INDIGO Aspiration SystemSummary page 4…ous catheter; 21 CFR 870.5150 (Class II) Information ProCode: QEZ Panel: Cardiovascular Predicate Penumbra INDIGOTM Aspiration System (K161523) Device Reference MIVI Q Distal Access Catheter (K192558) Device Device Description The Merlin Aspiration System is… | 2016 |
| † | K192558 | Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter… | 2020 |
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 21 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K161523.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213771: Merlin Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213771
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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