510(k) · Cleared
Recalled · Class II · 2024Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
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
Cleared on Feb 15, 2018 as substantially equivalent to DEN150049 (Concentric Medical, Inc., 2016) after a 113-day review. Its family tree reaches back 1 generation to 2016. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 15, 2018
- Review
- 113 days
- Class
- Class II
- Product code
- POL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150049 (2016). 6 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backDEN150049 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm…Concentric Medical, Inc. · 2016
- This deviceK173352 Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo…Concentric Medical, Inc. · 2018
- 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 · 3 generations on · 3 of its ownK200117 Trevo NXT ProVue RetrieverStryker · 2020
- Descendant · 2 generations on · 2 of its ownK203219 Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020
- Descendant · 3 generations on · 1 of its ownK210502 Trevo NXT ProVue RetrieverStryker Neurovascular · 2021
Showing 5 of 6 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 6 · See all- K190779Trevo XP ProVue RetrieverStryker · 2019 · cites it directly5descendants
- K192207Trevo NXT ProVue RetrieverStryker · 2019 · 2 generations on4descendants
- K200117Trevo NXT ProVue RetrieverStryker · 2020 · 3 generations on3descendants
- K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020 · 2 generations on2descendants
- K210502Trevo NXT ProVue RetrieverStryker Neurovascular · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP… | Concentric Medical, Inc. | 2016 | — |
| 0 (this device) | K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | Concentric Medical, Inc. | 2018 | — |
| +1 | K190779 | Trevo XP ProVue Retriever | Stryker | 2019 | Class I |
| +2 | K192207 | Trevo NXT ProVue Retriever | Stryker | 2019 | — |
| +3 | K200117 | Trevo NXT ProVue Retriever | Stryker | 2020 | — |
| +2 | K203219 | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever | Stryker Neurovascular | 2020 | — |
| +3 | K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 1 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 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
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 |
|---|---|---|---|
| * | DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue…Summary page 4…ialist Date Prepared: February 6, 2018 Predicate Device: Trevo ProVue Retriever and Trevo XP ProVue Retriever (DEN150049) Reference Predicate Trevo Retriever (K120961) Device: Device Description The Trevo Retriever family, including the T… | 2016 |
| † | K120961 | Trevo Retriever | 2012 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190779 | Trevo XP ProVue Retriever Class I | 2019 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2024 | Class II | Z-1902-2024 | Process design | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin… |
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?
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. 2018, 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?
1. The Trevo Retriever is indicated 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. 2. The Trevo…
Read the full statement (216 words)
1. The Trevo Retriever is indicated 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.
2. 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.
3. The Trevo Retriever is indicated 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173352: Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (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/K173352
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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