510(k) · Cleared
ClearedSolitaire FR Revascularization Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics Dba Ev3 Neurovascular · NRY Catheter, Thrombus Retriever
Cleared on Mar 2, 2012 as substantially equivalent to K062046 (Concentric Medical, Inc., 2007) and 6 other predicates after a 102-day review. Its family tree reaches back 5 generations to 2001. 1 of the 34 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it.
- Decided
- Mar 2, 2012
- Review
- 102 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K003410 (2001). 11 ancestors in all. 22 later devices descend from it, 5 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 4 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 3 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 2 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 1 generation backK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- This deviceK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · cites it directly · 18 of its ownK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · cites it directly · 17 of its ownK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- Descendant · cites it directly · 10 of its ownK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- Descendant · 2 generations on · 8 of its ownK160641 Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- Descendant · 2 generations on · 5 of its ownK203592 Tigertriever and Tigertriever 17 Revascularization DevceRapid Medical, Ltd. · 2021
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141516 Mindframe Capture LP Revascularization Devicecites it directly · 2015
Most influential descendants
Showing 5 of 22 · See all- K123378Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012 · cites it directly18descendants
- K141491Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014 · cites it directly17descendants
- K153071Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015 · cites it directly10descendants
- K160641Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017 · 2 generations on8descendants
- K203592Tigertriever and Tigertriever 17 Revascularization DevceRapid Medical, Ltd. · 2021 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −4 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −3 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −2 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −1 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| 0 (this device) | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +1 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +1 | K141491 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| +1 | K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| +2 | K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017 | — |
| +2 | K203592 | Tigertriever and Tigertriever 17 Revascularization Devce | Rapid Medical, Ltd. | 2021 | — |
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 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K062046 | Modified Merci Retriever, Model 90050Summary page 1…scularization Device Common Name of Device: Catheter, Thrombus Retriever Classification of Device: 21 CER 870.1250 -Class 11 Predicate Device: Merci® Retrievers (K(062046, K063774, K07052 1, K071 172, K081305, K082034, K090085) Device Description: The SolitaireTm FR Revascularization Device is int… | 2007 |
| * | K063774 | Modification to Merci Retriever, Models X5 and X6Summary page 1…ation Device Common Name of Device: Catheter, Thrombus Retriever Classification of Device: 21 CER 870.1250 -Class 11 Predicate Device: Merci® Retrievers (K(062046, K063774, K07052 1, K071 172, K081305, K082034, K090085) Device Description: The SolitaireTm FR Revascularization Device is intended to… | 2007 |
| * | K070521 | Modified Mercy Retriever, Model 90070Summary page 1…ice Common Name of Device: Catheter, Thrombus Retriever Classification of Device: 21 CER 870.1250 -Class 11 Predicate Device: Merci® Retrievers (K(062046, K063774, K07052 1, K071 172, K081305, K082034, K090085) Device Description: The SolitaireTm FR Revascularization Device is intended to restore bl… | 2007 |
| * | K071172 | Modified Merci Retriever, Model 90060Summary page 1…on Name of Device: Catheter, Thrombus Retriever Classification of Device: 21 CER 870.1250 -Class 11 Predicate Device: Merci® Retrievers (K(062046, K063774, K07052 1, K071 172, K081305, K082034, K090085) Device Description: The SolitaireTm FR Revascularization Device is intended to restore blood flow b… | 2007 |
| * | K081305 | Merci RetrieverSummary page 1…Device: Catheter, Thrombus Retriever Classification of Device: 21 CER 870.1250 -Class 11 Predicate Device: Merci® Retrievers (K(062046, K063774, K07052 1, K071 172, K081305, K082034, K090085) Device Description: The SolitaireTm FR Revascularization Device is intended to restore blood flow by removin… | 2008 |
| * | K082034 | Modification to Merci RetrieverSummary page 1…Catheter, Thrombus Retriever Classification of Device: 21 CER 870.1250 -Class 11 Predicate Device: Merci® Retrievers (K(062046, K063774, K07052 1, K071 172, K081305, K082034, K090085) Device Description: The SolitaireTm FR Revascularization Device is intended to restore blood flow by removing thrombu… | 2008 |
| * | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113Summary page 1…Thrombus Retriever Classification of Device: 21 CER 870.1250 -Class 11 Predicate Device: Merci® Retrievers (K(062046, K063774, K07052 1, K071 172, K081305, K082034, K090085) Device Description: The SolitaireTm FR Revascularization Device is intended to restore blood flow by removing thrombus from a… | 2009 |
What descends from it? (22)
See all 225 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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K123378 (Micro Therapeutics Dba Ev3 Neurovascular, 2012) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K062046.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 SolitaireTM FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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/K113455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113455: Solitaire FR Revascularization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113455
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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