510(k) · Cleared
ClearedTrevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Cleared on Dec 29, 2020 as substantially equivalent to K190779 (Stryker, 2019) and 1 other predicate after a 57-day review. Its family tree reaches back 8 generations to 2001. 1 of the 14 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Dec 29, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- POL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003410 (2001). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 7 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 6 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 5 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 4 generations backK120961 Trevo RetrieverConcentric Medical, Inc. · 2012 · Recalled
- 3 generations backK190779 Trevo XP ProVue RetrieverStryker · 2019 · Recalled (Class I)
- 2 generations backK192207 Trevo NXT ProVue RetrieverStryker · 2019
- 1 generation backK200117 Trevo NXT ProVue RetrieverStryker · 2020
- This deviceK203219 Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020
- Descendant · cites it directly · 1 of its ownK210502 Trevo NXT ProVue RetrieverStryker Neurovascular · 2021
- Descendant · 2 generations on · 0 of its ownK223305 Trevo NXT ProVue RetrieverStryker Neurovascular · 2023 · Recalled
Class I recalls in this family
- K190779 Trevo XP ProVue Retrieverdirect predicate · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −7 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −6 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −5 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −4 | K120961 | Trevo Retriever | Concentric Medical, Inc. | 2012 | 1 |
| −3 | K190779 | Trevo XP ProVue Retriever | Stryker | 2019 | Class I |
| −2 | K192207 | Trevo NXT ProVue Retriever | Stryker | 2019 | — |
| −1 | K200117 | Trevo NXT ProVue Retriever | Stryker | 2020 | — |
| 0 (this device) | K203219 | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever | Stryker Neurovascular | 2020 | — |
| +1 | K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K190779 | Trevo XP ProVue RetrieverSummary page 5…510(k) Manufacturer Number Trevo XP ProVue Stryker K190779 Retriever Neurovascular Trevo NXT™ ProVue Stryker… | 2019 |
| * | K200117 | Trevo NXT ProVue RetrieverSummary page 5…Stryker K190779 Retriever Neurovascular Trevo NXT™ ProVue Stryker K200117 Retriever Neurovascular Device Description The Trevo Retriever consists of a flexible, tape… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210502 | Trevo NXT ProVue Retriever | 2021 | 1 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210502 (Stryker Neurovascular, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K190779.
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. 2020, 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)-MI 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203219: Trevo XP ProVue Retriever and Trevo NXT™ 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/K203219
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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