510(k) · Cleared
ClearedMerci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
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 Feb 12, 2009 as substantially equivalent to K063774 (Concentric Medical, Inc., 2007) and 5 other predicates after a 30-day review. Its family tree reaches back 4 generations to 2001. 1 of the 34 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Feb 12, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K003410 (2001). 10 ancestors in all. 23 later devices descend from it, 1 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 3 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 2 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 1 generation backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- This deviceK090085 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
- Descendant · 2 generations on · 10 of its ownK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- Descendant · 3 generations on · 8 of its ownK160641 Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
Showing 5 of 23 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 23 · See all- 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
- K153071Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015 · 2 generations on10descendants
- K160641Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −3 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −2 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −1 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| +3 | K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K063774 | Modification to Merci Retriever, Models X5 and X6Summary page 1…ieval of foreign bodies misplaced during interventional radiological procedures in the. neuro, peripheral and coronary vasculature. Predicate Device Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034) Device Description Like the predicate devices, the design of the modified Merci Re… | 2007 |
| * | K062046 | Modified Merci Retriever, Model 90050Summary page 1…foreign bodies misplaced during interventional radiological procedures in the. neuro, peripheral and coronary vasculature. Predicate Device Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034) Device Description Like the predicate devices, the design of the modified Merci Retrievers… | 2007 |
| * | K071172 | Modified Merci Retriever, Model 90060Summary page 1…bodies misplaced during interventional radiological procedures in the. neuro, peripheral and coronary vasculature. Predicate Device Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034) Device Description Like the predicate devices, the design of the modified Merci Retrievers consists… | 2007 |
| * | K070521 | Modified Mercy Retriever, Model 90070Summary page 1…splaced during interventional radiological procedures in the. neuro, peripheral and coronary vasculature. Predicate Device Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034) Device Description Like the predicate devices, the design of the modified Merci Retrievers consists of a fle… | 2007 |
| * | K081305 | Merci RetrieverSummary page 1…uring interventional radiological procedures in the. neuro, peripheral and coronary vasculature. Predicate Device Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034) Device Description Like the predicate devices, the design of the modified Merci Retrievers consists of a flexible, ta… | 2008 |
| * | K082034 | Modification to Merci RetrieverSummary page 1…erventional radiological procedures in the. neuro, peripheral and coronary vasculature. Predicate Device Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034) Device Description Like the predicate devices, the design of the modified Merci Retrievers consists of a flexible, tapered Nit… | 2008 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113455 | Solitaire FR Revascularization Device | 2012 | 22 |
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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K113455 (Micro Therapeutics Dba Ev3 Neurovascular, 2012) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K063774.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing; ischemrc stroke. Patients who'are ineligible for treatment with intravenous tissue plasminogen activator (IVt-PA) or who fail IVt-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/K090085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090085: Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090085
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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