510(k) · Cleared
Recalled · Class I · 2020Trevo XP ProVue Retriever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Cleared on Jun 25, 2019 as substantially equivalent to K173352 (Concentric Medical, Inc., 2018) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 2001. 1 of the 14 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jun 25, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- POL
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003410 (2001). 8 ancestors in all. 5 later devices descend from it, 2 citing it directly. 1 of the 14 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 backK120961 Trevo RetrieverConcentric Medical, Inc. · 2012 · Recalled
- This deviceK190779 Trevo XP ProVue RetrieverStryker · 2019
- Descendant · cites it directly · 4 of its ownK192207 Trevo NXT ProVue RetrieverStryker · 2019
- Descendant · 2 generations on · 3 of its ownK200117 Trevo NXT ProVue RetrieverStryker · 2020
- Descendant · cites it directly · 2 of its ownK203219 Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020
- Descendant · 2 generations on · 1 of its ownK210502 Trevo NXT ProVue RetrieverStryker Neurovascular · 2021
- Descendant · 3 generations on · 0 of its ownK223305 Trevo NXT ProVue RetrieverStryker Neurovascular · 2023 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K192207Trevo NXT ProVue RetrieverStryker · 2019 · cites it directly4descendants
- K200117Trevo NXT ProVue RetrieverStryker · 2020 · 2 generations on3descendants
- K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020 · cites it directly2descendants
- K210502Trevo NXT ProVue RetrieverStryker Neurovascular · 2021 · 2 generations on1descendant
- K223305Trevo NXT ProVue RetrieverStryker Neurovascular · 2023 · 3 generations on0descendants
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 | K120961 | Trevo Retriever | Concentric Medical, Inc. | 2012 | 1 |
| 0 (this device) | K190779 | Trevo XP ProVue Retriever | Stryker | 2019 | — |
| +1 | K192207 | Trevo NXT ProVue Retriever | Stryker | 2019 | — |
| +2 | K200117 | Trevo NXT ProVue Retriever | Stryker | 2020 | — |
| +1 | K203219 | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever | Stryker Neurovascular | 2020 | — |
| +2 | K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021 | — |
| +3 | K223305 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Summary page 4…Senior Principal Regulatory Affairs Specialist Date Prepared: March 26, 2019 Primary Predicate Device: Trevo XP ProVue Retriever (K173352) Reference Predicate Trevo Retriever (K120961) Device: Device Description The Trevo Retriever consists of a flexible,… | 2018 |
| * | K120961 | Trevo RetrieverSummary page 4…s Specialist Date Prepared: March 26, 2019 Primary Predicate Device: Trevo XP ProVue Retriever (K173352) Reference Predicate Trevo Retriever (K120961) Device: Device Description The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal en… | 2012 |
What descends from it? (5)
2 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 |
|---|---|---|---|---|
| Sep 21, 2020 | Class I | Z-0114-2021 | Under Investigation by firm | Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K192207 (Stryker, 2019) has gone furthest, with 4 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. 2019, 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/K190779 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190779: Trevo XP ProVue Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190779
Report an extraction error
Are you the manufacturer?
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