510(k) · Cleared
ClearedTrevo NXT 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 Nov 22, 2019 as substantially equivalent to K190779 (Stryker, 2019) after a 100-day review. Its family tree reaches back 6 generations to 2001. 1 of the 14 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Nov 22, 2019
- Review
- 100 days
- Class
- Class II
- Product code
- POL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003410 (2001). 9 ancestors in all. 4 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 · 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 backK190779 Trevo XP ProVue RetrieverStryker · 2019 · Recalled (Class I)
- This deviceK192207 Trevo NXT ProVue RetrieverStryker · 2019
- Descendant · cites it directly · 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
- Descendant · 4 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 4 of 4 · See all- K200117Trevo NXT ProVue RetrieverStryker · 2020 · cites it directly3descendants
- K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020 · 2 generations on2descendants
- K210502Trevo NXT ProVue RetrieverStryker Neurovascular · 2021 · 3 generations on1descendant
- K223305Trevo NXT ProVue RetrieverStryker Neurovascular · 2023 · 4 generations on0descendants
View 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 | K190779 | Trevo XP ProVue Retriever | Stryker | 2019 | Class I |
| 0 (this device) | K192207 | Trevo NXT ProVue Retriever | Stryker | 2019 | — |
| +1 | 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 | — |
| +4 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K190779 | Trevo XP ProVue RetrieverSummary page 4…Senior Principal Regulatory Affairs Specialist Date Prepared: October 22, 2019 Primary Predicate Device: Trevo XP ProVue Retriever (K190779, cleared June 25, 2019) Reference Predicate AXS Catalyst Distal Access Catheter (K173841 cleared March 18, Device:… | 2019 |
| † | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058… | 2018 |
| † | K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | 2019 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200117 | Trevo NXT ProVue Retriever | 2020 | 3 |
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 18 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200117 (Stryker, 2020) has gone furthest, with 3 descendants 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. 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/K192207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192207: 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/K192207
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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