510(k) · Cleared
ClearedMerci Retriever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concentric Medical, Inc. · NRY Catheter, Thrombus Retriever
Cleared on Jun 5, 2008 as substantially equivalent to K071172 (Concentric Medical, Inc., 2007) after a 28-day review. Its family tree reaches back 1 generation to 2007. 1 of the 27 devices in its family, counting itself, has a Class I recall. 25 later devices descend from it.
- Decided
- Jun 5, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071172 (2007). 25 later devices descend from it, 3 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK071172 Modified Merci Retriever, Model 90060Concentric Medical, Inc. · 2007
- This deviceK081305 Merci RetrieverConcentric Medical, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK082034 Modification to Merci RetrieverConcentric Medical, Inc. · 2008 · Recalled
- Descendant · cites it directly · 23 of its ownK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- Descendant · cites it directly · 22 of its ownK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · 2 generations on · 18 of its ownK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · 2 generations on · 17 of its ownK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141516 Mindframe Capture LP Revascularization Device2 generations on · 2015
Most influential descendants
Showing 5 of 25 · See all- K082034Modification to Merci RetrieverConcentric Medical, Inc. · 2008 · cites it directly24descendants
- K090085Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113Concentric Medical, Inc. · 2009 · cites it directly23descendants
- K113455Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012 · cites it directly22descendants
- K123378Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012 · 2 generations on18descendants
- K141491Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071172 | Modified Merci Retriever, Model 90060 | Concentric Medical, Inc. | 2007 | — |
| 0 (this device) | K081305 | Merci Retriever | Concentric Medical, Inc. | 2008 | — |
| +1 | K082034 | Modification to Merci Retriever | Concentric Medical, Inc. | 2008 | 1 |
| +1 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| +1 | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +2 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +2 | K141491 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 NRY device
- #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 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 |
|---|---|---|---|
| * | K071172 | Modified Merci Retriever, Model 90060Summary page 1…ieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascuiature. Predicate Device MerclK Retr~ever .K1071172 Device Description Like the ored cate device, the design of the modified blerci Retriever consists of a flex ble, tapered Nitin… | 2007 |
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141516Mindframe Capture LP Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NRY
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRY
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NRY
4in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · NRY
565in 2025
MAUDE reports naming product code NRY, 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 | 5 | 94 | 0 | 13 |
| 2008 | 2 | — | 0 | 18 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 289 |
| 2011 | 2 | — | 0 | 263 |
| 2012 | 4 | 90 | 0 | 366 |
| 2013 | 0 | — | 1 | 405 |
| 2014 | 4 | 140 | 0 | 428 |
| 2015 | 6 | 128 | 0 | 598 |
| 2016 | 5 | 75 | 0 | 497 |
| 2017 | 3 | 185 | 4 | 432 |
| 2018 | 11 | 156 | 0 | 415 |
| 2019 | 7 | 89 | 0 | 650 |
| 2020 | 6 | 125 | 4 (4) | 703 |
| 2021 | 9 | 80 | 0 | 688 |
| 2022 | 3 | 129 | 0 | 549 |
| 2023 | 8 | 112 | 0 | 711 |
| 2024 | 8 | 165 | 0 | 641 |
| 2025 | 15 | 129 | 0 | 565 |
| 2026 | 14 | 147 | 2 | — |
What is it indicated for?
The Mercio Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IVt-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081305 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081305: Merci Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081305
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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