510(k) · Cleared
Recalled · Class II · 2017Modified Trevo Provue 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 Jan 13, 2014 as substantially equivalent to K122478 (Concentric Medical, Inc., 2012) after a 140-day review. Its family tree reaches back 6 generations to 2001. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 13, 2014
- Review
- 140 days
- Class
- Class II
- Product code
- NRY
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003410 (2001). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 5 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 4 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 3 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 2 generations backK120961 Trevo RetrieverConcentric Medical, Inc. · 2012 · Recalled
- 1 generation backK122478 Modified Trevo RetrieverConcentric Medical, Inc. · 2012
- This deviceK132641 Modified Trevo Provue RetrieverConcentric Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK150616 Trevo XP ProVue Retriever (4x30mm)Concentric Medical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK143077 Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK211120 ERIC Retrieval DeviceMicroVention, Inc. · 2022 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −5 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −4 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −3 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −2 | K120961 | Trevo Retriever | Concentric Medical, Inc. | 2012 | 1 |
| −1 | K122478 | Modified Trevo Retriever | Concentric Medical, Inc. | 2012 | — |
| 0 (this device) | K132641 | Modified Trevo Provue Retriever | Concentric Medical, Inc. | 2014 | — |
| +1 | K150616 | Trevo XP ProVue Retriever (4x30mm) | Concentric Medical, Inc. | 2015 | — |
| +1 | K143077 | Trevo XP ProVue Retriever (6X25mm) | Concentric Medical, Inc. | 2015 | 3 |
| +1 | K211120 | ERIC Retrieval Device | MicroVention, Inc. | 2022 | 1 |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2022 | 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.
Planning a device in NRY? 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 |
|---|---|---|---|
| * | K122478 | Modified Trevo RetrieverSummary page 1…Meyer Senior Regulatory Affairs Specialist Date Prepared: February 25, 2014 Predicate Device: Concentric Trevo ProVue Retriever (K122478) Device Description The Modified Trevo ProVue Retriever consists of a flexible, tapered core wire with a shaped section at the… | 2012 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2017 | Class II | Z-0347-2018 | Packaging process control | Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack. |
| Nov 3, 2017 | Class II | Z-0275-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
| Nov 3, 2017 | Class II | Z-0276-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
| Nov 3, 2017 | Class II | Z-0277-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K150616 (Concentric Medical, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122478.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ischemnic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IVt-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/K132641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132641: Modified Trevo Provue Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132641
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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