Cleared Traditional

K231539 - pRESET LITE Thrombectomy Device (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231539 · Phenox Limited · Neurology device
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Oct 2023
Decision
144d
Days
Class 2
Risk

K231539 is an FDA 510(k) clearance for the pRESET LITE Thrombectomy Device. Classified as Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (product code POL), Class II - Special Controls.

Submitted by Phenox Limited (Galway, IE). The FDA issued a Cleared decision on October 21, 2023 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5600 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K231539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date October 21, 2023
Days to Decision 144 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 148d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5600
Definition A Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Is A Prescription Device Used In The Treatment Of Acute Ischemic Stroke To Improve Clinical Outcomes. The Device Is Delivered Into The Neurovasculature With An Endovascular Approach, Mechanically Removes Thrombus From The Body, And Restores Blood Flow In The Neurovasculature.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

All 17
Devices cleared under the same product code (POL) and FDA review panel - the closest regulatory comparables to K231539.
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
K242676 · Phenox Limited · Feb 2025
Trevo NXT ProVue Retriever
K223305 · Stryker Neurovascular · Mar 2023
pRESET Thrombectomy Device
K222848 · Phenox Limited · Jan 2023
Trevo NXT ProVue Retriever
K210502 · Stryker Neurovascular · Aug 2021
Solitaire X Revascularization Device
K203358 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Mar 2021
Trevo NXT ProVue Retriever
K200117 · Stryker · Feb 2020