510(k) · Cleared
ClearedSolitaire X 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 Mar 1, 2021 as substantially equivalent to K183022 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2019) and 1 other predicate after a 105-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Mar 1, 2021
- Review
- 105 days
- Class
- Class II
- Product code
- POL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K003410 (2001). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK161879 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016
- 2 generations backK181186 Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- 1 generation backK183022 Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019
- This deviceK203358 Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
Show all 12 generations
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 11 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 10 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 9 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 8 generations backK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- 7 generations backK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 6 generations backK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 5 generations backK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 4 generations backK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 3 generations backK161879 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016
- 2 generations backK181186 Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- 1 generation backK183022 Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2019
- This deviceK203358 Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −11 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −10 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −9 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −8 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| −7 | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −6 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −5 | K141491 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| −4 | K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| −3 | K161879 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016 | — |
| −2 | K181186 | Solitare Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018 | — |
| −1 | K183022 | Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019 | — |
| 0 (this device) | K203358 | Solitaire X Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021 | — |
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 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K183022 | Solitaire 4 Revascularization DeviceSummary page 4…roduct Code: POL; NRY Predicate Device: Primary Predicate Device: Solitaire™ 4 Revascularization Device (K183022) Additional Predicate Device: Solitaire™ 2 Revascularization D… | 2019 |
| * | K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device…Summary page 4…ularization Device, Solitaire™ Platinum Revascularization Device (Solitaire™ Revascularization Device) (K181807) Device Description The subject 3 mm Solitaire™ X Revascularization Device is designed to restore blood flow in patients exper… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K183022.
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. 2021, 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™ X 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 (219 words)
1. The Solitaire™ X 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™ X 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.
3. The Solitaire™ X 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-Ml segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 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/K203358 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203358: Solitaire X Revascularization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203358
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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