Cleared Traditional

K151354 - Cervello STIM

K151354 is an FDA 510(k) clearance for Cervello STIM, manufactured by Blackrock Neuromed. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K151354 · Blackrock Neuromed · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
252d
Days
Class 2
Risk

K151354 is an FDA 510(k) clearance for the Cervello STIM. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Blackrock Neuromed (Salt Lake City, US). The FDA issued a Cleared decision on January 27, 2016 after a review of 252 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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 Blackrock Neuromed devices

FDA 510(k) Submission Details - K151354

510(k) Number K151354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2015
Decision Date January 27, 2016
Days to Decision 252 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 148d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYC Device Classification - Class 2, Special Controls

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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 - GYC Electrode, Cortical

All 19
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K151354.
AirRay Subdural Cortical Electrodes
K183437 · Cortec GmbH · Mar 2019
SD LTM STIM Cortical Stimulator
K180761 · Micromed S.P.A. · Jun 2018
g.Estim PRO
K173684 · G.Tec Medical Engineering GmbH · May 2018
INTEGRA ELECTRODE TUNNELING NEEDLE
K102802 · Integra LifeSciences Corporation · Nov 2010
PMT SUBDURAL CORTICAL ELECTRODES
K082474 · Pmt Corp. · May 2009
NICOLET CORTICAL STIMULATOR
K072964 · Cardinal Health, Inc. · Dec 2008