Cleared Special

K242676 - pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242676 · Phenox Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
175d
Days
Class 2
Risk

K242676 is an FDA 510(k) clearance for the pRESET Delta Thrombectomy Device and pRESET Delta 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 February 28, 2025 after a review of 175 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5600 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Phenox Limited devices

Submission Details

510(k) Number K242676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2024
Decision Date February 28, 2025
Days to Decision 175 days
Submission Type Special
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
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Modification to existing cleared device.

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 K242676.
pRESET LITE Thrombectomy Device
K231539 · Phenox Limited · Oct 2023
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 XP ProVue Retriever and Trevo NXT™ ProVue Retriever
K203219 · Stryker Neurovascular · Dec 2020