Cleared Abbreviated

K090957 - BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM

K090957 is an FDA 510(k) clearance for BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL..., manufactured by I2s Micro Implantable Systems, LLC. The device is a Class 2 Neurology device with product code GWL cleared through the Abbreviated 510(k) pathway after a 52-day FDA review.

K090957 · I2s Micro Implantable Systems, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
52d
Days
Class 2
Risk

K090957 is an FDA 510(k) clearance for the BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by I2s Micro Implantable Systems, LLC (Stoughton, US). The FDA issued a Cleared decision on May 28, 2009 after a review of 52 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K090957

510(k) Number K090957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date May 28, 2009
Days to Decision 52 days
Submission Type Abbreviated
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
97d faster than avg
Panel avg: 149d · This submission: 52d
Pathway characteristics
Standards-based clearance path.

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 46
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K090957.
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
K121996 · Eb Neuro S.P.A. · Aug 2012
NICOLET WIRELESS EEG
K103140 · Carefusion 209, Inc. · Apr 2011
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
K092699 · Neurotronics, Inc. · Mar 2010
NEUROMETRIX BIOAMPLIFIER
K083322 · Neurometrix, Inc. · May 2009
PORTI 7 PHYSIOLOGICAL AMPLIFIER
K063599 · Tms International BV · Mar 2007
REFA, PHYSIOLOGICAL AMPLIFIER
K060374 · Tms International BV · May 2006
K090957 · BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
Download PDF FDA Summary I2s Micro Implantable…