510(k) · Cleared
Recalled · Class II · 2024Trevo 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 Mar 29, 2023 as substantially equivalent to K210502 (Stryker Neurovascular, 2021) after a 153-day review. Its family tree reaches back 10 generations to 2001. 1 of the 14 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Mar 29, 2023
- Review
- 153 days
- Class
- Class II
- Product code
- POL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003410 (2001). 13 ancestors in all. No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK200117 Trevo NXT ProVue RetrieverStryker · 2020
- 2 generations backK203219 Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020
- 1 generation backK210502 Trevo NXT ProVue RetrieverStryker Neurovascular · 2021
- This deviceK223305 Trevo NXT ProVue RetrieverStryker Neurovascular · 2023
Show all 10 generations
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 9 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 8 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 7 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 6 generations backK120961 Trevo RetrieverConcentric Medical, Inc. · 2012 · Recalled
- 5 generations backK190779 Trevo XP ProVue RetrieverStryker · 2019 · Recalled (Class I)
- 4 generations backK192207 Trevo NXT ProVue RetrieverStryker · 2019
- 3 generations backK200117 Trevo NXT ProVue RetrieverStryker · 2020
- 2 generations backK203219 Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular · 2020
- 1 generation backK210502 Trevo NXT ProVue RetrieverStryker Neurovascular · 2021
- This deviceK223305 Trevo NXT ProVue RetrieverStryker Neurovascular · 2023
Class I recalls in this family
- K190779 Trevo XP ProVue Retriever3 generations back · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −9 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −8 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −7 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −6 | K120961 | Trevo Retriever | Concentric Medical, Inc. | 2012 | 1 |
| −5 | K190779 | Trevo XP ProVue Retriever | Stryker | 2019 | Class I |
| −4 | 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 | — |
| −1 | K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021 | — |
| 0 (this device) | K223305 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K210502 | Trevo NXT ProVue RetrieverSummary page 4…510(k) Manufacturer Number Trevo NXT ProVue Stryker K210502 Retriever Neurovascular… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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-1905-2024 | 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
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. 2023, 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 (212 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 (0-50cc for age <80 years, 0-20cc 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/K223305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223305: 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/K223305
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