510(k) · Cleared
ClearedSolitaire 4 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 Jan 29, 2019 as substantially equivalent to K181186 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2018) after an 89-day review. Its family tree reaches back 11 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 29, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- POL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K003410 (2001). 20 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 7 generations between
- 3 generations backK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 2 generations backK161879 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016
- 1 generation backK181186 Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- This deviceK183022 Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019
- Descendant · cites it directly · 0 of its ownK203358 Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
- Descendant · cites it directly · 0 of its ownK193576 Solitaire Platinum Revascularization Device, Solitaire X…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
Show all 11 generations
- Root · 11 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 10 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 9 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 8 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 7 generations backK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- 6 generations backK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 5 generations backK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 4 generations backK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 3 generations backK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 2 generations backK161879 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016
- 1 generation backK181186 Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- This deviceK183022 Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019
Most influential descendants
Showing 2 of 2 · See all- K203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · cites it directly0descendants
- K193576Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −10 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −9 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −8 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −7 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| −6 | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −5 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −4 | K141491 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| −3 | K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| −2 | K161879 | Solitaire Platinum 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 | — |
| 0 (this device) | K183022 | Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019 | — |
| +1 | K203358 | Solitaire X Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021 | — |
| +1 | K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization… | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K181186 | Solitare Platinum Revascularization DeviceSummary page 4…cation of Class II, 21 CFR 882.5600; 21 CFR 870.1250 Device: Product Code: POL; NRY Predicate Device: Solitaire™ Platinum Revascularization Device (K181186) Device Description: The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischem… | 2018 |
What descends from it? (2)
2 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K203358 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181186.
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 Solitaire™ 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 (115 words)
1. The Solitaire™ 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/K183022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183022: Solitaire 4 Revascularization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183022
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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