Cleared Traditional

K123255 - g.HIamp

K123255 is an FDA 510(k) clearance for g.HIamp, manufactured by G.Tec Medical Engineering GmbH. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K123255 · G.Tec Medical Engineering GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
63d
Days
Class 2
Risk

K123255 is an FDA 510(k) clearance for the g.HIamp. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AT). The FDA issued a Cleared decision on December 20, 2012 after a review of 63 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.

View all G.Tec Medical Engineering GmbH devices

FDA 510(k) Submission Details - K123255

510(k) Number K123255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2012
Decision Date December 20, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWL Amplifier, Physiological Signal

All 28
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K123255.
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NEUROMETRIX BIOAMPLIFIER
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