Cleared Special

K121996 - BE PLUS LTM AMPLIFIER GWI AMPLIFIER

K121996 is an FDA 510(k) clearance for BE PLUS LTM AMPLIFIER GWI AMPLIFIER, manufactured by Eb Neuro S.P.A.. The device is a Class 2 Neurology device with product code GWL cleared through the Special 510(k) pathway after a 25-day FDA review.

K121996 · Eb Neuro S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
25d
Days
Class 2
Risk

K121996 is an FDA 510(k) clearance for the BE PLUS LTM AMPLIFIER GWI AMPLIFIER. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Eb Neuro S.P.A. (Indianapolis, US). The FDA issued a Cleared decision on August 3, 2012 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eb Neuro S.P.A. devices

FDA 510(k) Submission Details - K121996

510(k) Number K121996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2012
Decision Date August 03, 2012
Days to Decision 25 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
124d faster than avg
Panel avg: 149d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 37
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K121996.
R-40 EEG Amplifier
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K092699 · Neurotronics, Inc. · Mar 2010
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
K090957 · I2s Micro Implantable Systems, LLC · May 2009