510(k) · Cleared
Recalled · Class II · 2013Trevo 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 Aug 3, 2012 as substantially equivalent to K063774 (Concentric Medical, Inc., 2007) after a 126-day review. Its family tree reaches back 4 generations to 2001. 1 of the 23 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it. It has been recalled once.
- Decided
- Aug 3, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- NRY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003410 (2001). 5 ancestors in all. 17 later devices descend from it, 2 citing it directly. 1 of the 23 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 deviceK120961 Trevo RetrieverConcentric Medical, Inc. · 2012
- Descendant · cites it directly · 10 of its ownK122478 Modified Trevo RetrieverConcentric Medical, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK190779 Trevo XP ProVue RetrieverStryker · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK192207 Trevo NXT ProVue RetrieverStryker · 2019
- Descendant · 2 generations on · 4 of its ownK173452 EmboTrap ll Revascularization DeviceNeuravi, Ltd. · 2018
- Descendant · 3 generations on · 3 of its ownK193063 EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190779 Trevo XP ProVue Retrievercites it directly · 2019
Most influential descendants
Showing 5 of 17 · See all- K122478Modified Trevo RetrieverConcentric Medical, Inc. · 2012 · cites it directly10descendants
- K190779Trevo XP ProVue RetrieverStryker · 2019 · cites it directly5descendants
- K192207Trevo NXT ProVue RetrieverStryker · 2019 · 2 generations on4descendants
- K173452EmboTrap ll Revascularization DeviceNeuravi, Ltd. · 2018 · 2 generations on4descendants
- K193063EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2020 · 3 generations on3descendants
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) | K120961 | Trevo Retriever | Concentric Medical, Inc. | 2012 | — |
| +1 | K122478 | Modified Trevo Retriever | Concentric Medical, Inc. | 2012 | — |
| +1 | K190779 | Trevo XP ProVue Retriever | Stryker | 2019 | Class I |
| +2 | K192207 | Trevo NXT ProVue Retriever | Stryker | 2019 | — |
| +2 | K173452 | EmboTrap ll Revascularization Device | Neuravi, Ltd. | 2018 | — |
| +3 | K193063 | EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
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 |
|---|---|---|---|
| * | K063774 | Modification to Merci Retriever, Models X5 and X6Summary page 1…Kirsten Valley Vice President, Technology & Regulatory Affairs Date Prepared: July 27, 2012 Predicate Device: Merci® Retriever (K063774) Device Description Like the predicate device, the Trevo Retriever consists of a flexible, tapered core wire with a shaped sec… | 2007 |
What descends from it? (17)
See all 172 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2013 | Class II | Z-0528-2015 | Process control | Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications. |
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.
- K190779Trevo XP ProVue RetrieverStryker · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K122478 (Concentric Medical, Inc., 2012) has gone furthest, with 10 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. 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 Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus 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 as stated in the FDA summary.
https://510kreport.com/device/K120961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120961: Trevo Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120961
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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