Cleared Traditional

K123915 - DE48-PLUS

K123915 is an FDA 510(k) clearance for DE48-PLUS, manufactured by Grass Technologies, an Astro-Med, Inc. Product Gro. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K123915 · Grass Technologies, an Astro-Med, Inc. Product Gro · Neurology device
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Apr 2013
Decision
126d
Days
Class 2
Risk

K123915 is an FDA 510(k) clearance for the DE48-PLUS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Grass Technologies, an Astro-Med, Inc. Product Gro (Rockland, US). The FDA issued a Cleared decision on April 24, 2013 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Grass Technologies, an Astro-Med, Inc. Product Gro devices

FDA 510(k) Submission Details - K123915

510(k) Number K123915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date April 24, 2013
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 227
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K123915.
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K120516 · Omron Healthcare, Inc. · May 2012