Cleared Traditional

K051852 - SINGLE AMPLIFIER FOR BOTOX

K051852 is an FDA 510(k) clearance for SINGLE AMPLIFIER FOR BOTOX, manufactured by Allergan, Inc.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K051852 · Allergan, Inc. · Neurology device
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Sep 2005
Decision
68d
Days
Class 2
Risk

K051852 is an FDA 510(k) clearance for the SINGLE AMPLIFIER FOR BOTOX. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 68 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051852

510(k) Number K051852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2005
Decision Date September 14, 2005
Days to Decision 68 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 149d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 52
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K051852.
REFA, PHYSIOLOGICAL AMPLIFIER
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K052060 · Intelligent Hearing Systems · Aug 2005
NIC36 AMPLIFIER
K041198 · Eb Neuro S.P.A. · Jun 2004
SANDMAN SD20 AMPLIFIER
K040113 · Eb Neuro S.P.A. · Feb 2004
K051852 · SINGLE AMPLIFIER FOR BOTOX
Download PDF Allergan, Inc.