Cleared Traditional

K222848 - pRESET Thrombectomy Device (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K222848 · Phenox Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
121d
Days
Class 2
Risk

K222848 is an FDA 510(k) clearance for the pRESET 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 January 20, 2023 after a review of 121 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.

View all Phenox Limited devices

Submission Details

510(k) Number K222848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2022
Decision Date January 20, 2023
Days to Decision 121 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
27d faster than avg
Panel avg: 148d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03994822 Completed Interventional Industry-sponsored

pRESET for Occlusive Stroke Treatment

340
Patients (actual)
24
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Brain Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Ischemia; Nervous System Diseases; Pathologic Processes; Stroke, Ischemic; Stroke, Acute; Vascular Diseases
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Raul G Nogueira, MD
Sponsor phenox Inc. (industry)
Started 2019-10-04 → Primary completion 2022-05-12
Primary outcome
Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS)
Secondary outcome
Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K222848.
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
K242676 · Phenox Limited · Feb 2025
pRESET LITE Thrombectomy Device
K231539 · Phenox Limited · Oct 2023
Trevo NXT ProVue Retriever
K223305 · Stryker Neurovascular · Mar 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