510(k) · Cleared
ClearedpRESET Thrombectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phenox Limited · POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Cleared on Jan 20, 2023 as substantially equivalent to K162539 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2016) after a 121-day review. Its family tree reaches back 2 generations to 2016. 2 later devices descend from it.
- Decided
- Jan 20, 2023
- Review
- 121 days
- Class
- Class II
- Product code
- POL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150049 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN150049 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm…Concentric Medical, Inc. · 2016
- 1 generation backK162539 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2016
- This deviceK222848 pRESET Thrombectomy DevicePhenox Limited · 2023
- Descendant · cites it directly · 1 of its ownK231539 pRESET LITE Thrombectomy DevicePhenox Limited · 2023
- Descendant · cites it directly · 0 of its ownK242676 pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy…Phenox Limited · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP… | Concentric Medical, Inc. | 2016 | — |
| −1 | K162539 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016 | — |
| 0 (this device) | K222848 | pRESET Thrombectomy Device | Phenox Limited | 2023 | — |
| +1 | K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | 2023 | — |
| +1 | K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | Phenox Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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 K242676 pRESET Delta Thrombectomy Device and pRESET…score 9.8 · 4 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 |
|---|---|---|---|
| * | K162539 | Solitaire 2 Revascularization DeviceSummary page 4…2.5600; 21 CFR 870.1250 Product Code: POL, NRY Review Panel: Neurology III. PREDICATE DEVICE Device Name: Solitaire™ 2 Revascularization Device, K162539. 510(k) Submitter: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular IV. DEVICE DESCRIPTION The pRESET® Thrombe… | 2016 |
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 7 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231539 (Phenox Limited, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K162539.
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 pRESET® Thrombectomy 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 thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The pRESET®…
Read the full statement (110 words)
1. The pRESET® Thrombectomy 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 thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
2. The pRESET® Thrombectomy 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 thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222848: pRESET Thrombectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222848
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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