Cleared Traditional

K242345 - Delphi Stimulator

K242345 is an FDA 510(k) clearance for Delphi Stimulator, manufactured by Quantalx Neuroscience. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K242345 · Quantalx Neuroscience · Neurology device
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Nov 2024
Decision
90d
Days
Class 2
Risk

K242345 is an FDA 510(k) clearance for the Delphi Stimulator. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Quantalx Neuroscience (Kfar Sava, IL). The FDA issued a Cleared decision on November 5, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Neuroscience devices

FDA 510(k) Submission Details - K242345

510(k) Number K242345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2024
Decision Date November 05, 2024
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 60
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K242345.
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