510(k) · Cleared
ClearedSolitaire 2 Revascularization Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Cleared on Nov 10, 2016 as substantially equivalent to DEN150049 (Concentric Medical, Inc., 2016) after a 59-day review. Its family tree reaches back 1 generation to 2016. 9 later devices descend from it.
- Decided
- Nov 10, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- POL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150049 (2016). 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN150049 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm…Concentric Medical, Inc. · 2016
- This deviceK162539 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016
- Descendant · cites it directly · 3 of its ownK181186 Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- Descendant · cites it directly · 2 of its ownK222848 pRESET Thrombectomy DevicePhenox Limited · 2023
- Descendant · cites it directly · 2 of its ownK181807 Solitaire 2 Revascularization Device, Solitaire Platinum…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019
- Descendant · 2 generations on · 2 of its ownK183022 Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019
- Descendant · 2 generations on · 1 of its ownK231539 pRESET LITE Thrombectomy DevicePhenox Limited · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018 · cites it directly3descendants
- K222848pRESET Thrombectomy DevicePhenox Limited · 2023 · cites it directly2descendants
- K181807Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019 · cites it directly2descendants
- K183022Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019 · 2 generations on2descendants
- K231539pRESET LITE Thrombectomy DevicePhenox Limited · 2023 · 2 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) | K162539 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016 | — |
| +1 | K181186 | Solitare Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018 | — |
| +1 | K222848 | pRESET Thrombectomy Device | Phenox Limited | 2023 | — |
| +1 | K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization… | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019 | — |
| +2 | K183022 | Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019 | — |
| +2 | K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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.
Planning a device in POL? 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…Classification of Class II, 21 CFR 882.5600, 21 CFR 870.1250 Device: Product Code: POL, NRY Predicate Devices: Trevo XP ProVue Retriever DEN150049 Clinical Data: A global, multicenter, two-arm, prospective, randomized, open, blinded endpoint (PROBE… | 2016 |
| † | K141491 | Solitaire 2 Revascularization Device | 2014 |
| † | K113455 | Solitaire FR Revascularization Device | 2012 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a 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. 2016, 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 Solitaire™ 2 Revascularization Device 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 be started within 6 hours of…
Read the full statement (116 words)
1. The Solitaire™ 2 Revascularization Device 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 be started within 6 hours of symptom onset.
2. The Solitaire™ Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162539: Solitaire 2 Revascularization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162539
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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