Cleared Traditional

K002832 - CONDUCTIVE GEL FOR ULTRASOUND

K002832 is an FDA 510(k) clearance for CONDUCTIVE GEL FOR ULTRASOUND, manufactured by Skylark Device & Systems Co., Ltd.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K002832 · Skylark Device & Systems Co., Ltd. · Neurology device
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Aug 2001
Decision
329d
Days
Class 2
Risk

K002832 is an FDA 510(k) clearance for the CONDUCTIVE GEL FOR ULTRASOUND. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Skylark Device & Systems Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on August 6, 2001 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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. Elevated predicate reliance profile. 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 Skylark Device & Systems Co., Ltd. devices

FDA 510(k) Submission Details - K002832

510(k) Number K002832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2000
Decision Date August 06, 2001
Days to Decision 329 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 148d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 29
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K002832.
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TEN-20 CONDUCTIVE PASTE GEL
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OMNI PREP GEL
K933797 · Cadwell Laboratories, Inc. · May 1994