De Novo · Granted
GrantedModified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concentric Medical, Inc. · POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Granted on Sep 2, 2016 as a new device type through De Novo after a 312-day review. 1 of the 18 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Sep 2, 2016
- Review
- 312 days
- Class
- Class II
- Product code
- POL
- Recalls
- None
17 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- This deviceDEN150049 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm…Concentric Medical, Inc. · 2016
- Descendant · cites it directly · 9 of its ownK162539 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016
- Descendant · cites it directly · 6 of its ownK173352 Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo…Concentric Medical, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 5 of its ownK190779 Trevo XP ProVue RetrieverStryker · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK192207 Trevo NXT ProVue RetrieverStryker · 2019
- Descendant · 4 generations on · 3 of its ownK200117 Trevo NXT ProVue RetrieverStryker · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190779 Trevo XP ProVue Retriever2 generations on · 2019
Most influential descendants
Showing 5 of 17 · See all- K162539Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016 · cites it directly9descendants
- K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. · 2018 · cites it directly6descendants
- K190779Trevo XP ProVue RetrieverStryker · 2019 · 2 generations on5descendants
- K192207Trevo NXT ProVue RetrieverStryker · 2019 · 3 generations on4descendants
- K200117Trevo NXT ProVue RetrieverStryker · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP… | Concentric Medical, Inc. | 2016 | — |
| +1 | K162539 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016 | — |
| +1 | K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | Concentric Medical, Inc. | 2018 | 1 |
| +2 | K190779 | Trevo XP ProVue Retriever | Stryker | 2019 | Class I |
| +3 | K192207 | Trevo NXT ProVue Retriever | Stryker | 2019 | — |
| +4 | K200117 | Trevo NXT ProVue Retriever | Stryker | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 1 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 POL device
- #1 K222848 pRESET Thrombectomy Devicescore 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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)
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.
- K190779Trevo XP ProVue RetrieverStryker · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K162539 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2016) has gone furthest, with 9 descendants of its own.
How does its category compare?
All POL devicesPOL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · POL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POL
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POL
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · POL
16in 2025
MAUDE reports naming product code POL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | 123 | 0 | 0 |
| 2019 | 4 | 95 | 0 | 1 |
| 2020 | 3 | 57 | 1 (1) | 6 |
| 2021 | 2 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 3 | 144 | 0 | 23 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150049 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150049: Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150049
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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