Cleared Traditional

K243746 - Delphi Amplifier

K243746 is an FDA 510(k) clearance for Delphi Amplifier, manufactured by Quantalx Neroscience. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K243746 · Quantalx Neroscience · Neurology device
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Mar 2025
Decision
97d
Days
Class 2
Risk

K243746 is an FDA 510(k) clearance for the Delphi Amplifier. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Quantalx Neroscience (Kfar Sava, IL). The FDA issued a Cleared decision on March 12, 2025 after a review of 97 days - within the typical 510(k) review window.

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: 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 Quantalx Neroscience devices

FDA 510(k) Submission Details - K243746

510(k) Number K243746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2024
Decision Date March 12, 2025
Days to Decision 97 days
Submission Type Traditional
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
51d faster than avg
Panel avg: 148d · This submission: 97d
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 Consultant

ProMedoss, Inc.
Bosmat Friedman-Cox

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 18
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