Cleared Traditional

K933797 - OMNI PREP GEL

K933797 is an FDA 510(k) clearance for OMNI PREP GEL, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K933797 · Cadwell Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
286d
Days
Class 2
Risk

K933797 is an FDA 510(k) clearance for the OMNI PREP GEL. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 286 days - an extended review cycle.

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. 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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K933797

510(k) Number K933797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date May 17, 1994
Days to Decision 286 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
138d slower than avg
Panel avg: 148d · This submission: 286d
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 30
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K933797.
MODEL 1700, HYDRO PREP
K970694 · Physiometrix, Inc. · May 1997
MEDI-TRACE DEFIB PADS
K955597 · Graphic Controls Corp. · Jul 1996
TEN-20 CONDUCTIVE PASTE GEL
K933799 · Cadwell Laboratories, Inc. · May 1994
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · Cadwell Laboratories, Inc. · Mar 1994
ELECTROCONDUCTIVE MEDIA
K904377 · Henley Intl. · Nov 1991
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · Henley Intl. · Jul 1990