510(k) · Cleared
ClearedModified Merci Retriever, Model 90092
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 May 25, 2006 after a 38-day review. The FDA summary names its predicate without a number. 2 of the 39 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it.
- Decided
- May 25, 2006
- Review
- 38 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 1 citing it directly. 2 of the 39 devices in this family, counting this one, have a Class I recall.
- This deviceK061059 Modified Merci Retriever, Model 90092Concentric Medical, Inc. · 2006
- Descendant · cites it directly · 37 of its ownK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- Descendant · 2 generations on · 23 of its ownK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- Descendant · 2 generations on · 22 of its ownK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · 3 generations on · 18 of its ownK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · 3 generations on · 17 of its ownK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 38 · See all- K063774Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007 · cites it directly37descendants
- K090085Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113Concentric Medical, Inc. · 2009 · 2 generations on23descendants
- K113455Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012 · 2 generations on22descendants
- K123378Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012 · 3 generations on18descendants
- K141491Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061059 | Modified Merci Retriever, Model 90092 | Concentric Medical, Inc. | 2006 | — |
| +1 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| +2 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| +2 | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +3 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +3 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 1 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | — | Merci Retriever X6 Named without a submission number |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063774 | Modification to Merci Retriever, Models X5 and X6 | 2007 | 37 |
Has anything in its family been recalled? (2 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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K190779Trevo XP ProVue RetrieverStryker · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K063774 (Concentric Medical, Inc., 2007) has gone furthest, with 37 descendants of its own.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Modified Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Modified 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/K061059 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061059: Modified Merci Retriever, Model 90092.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061059
Report an extraction error
Are you the manufacturer?
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