Cleared Traditional

K771893 - DISPOSABLE ELHCTRODE

K771893 is an FDA 510(k) clearance for DISPOSABLE ELHCTRODE, manufactured by Chase Medical Services. The device is a Class 2 Chemistry device with product code GYB cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K771893 · Chase Medical Services · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1977
Decision
117d
Days
Class 2
Risk

K771893 is an FDA 510(k) clearance for the DISPOSABLE ELHCTRODE. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Chase Medical Services (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 882.1275 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Chase Medical Services devices

FDA 510(k) Submission Details - K771893

510(k) Number K771893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1977
Decision Date November 02, 1977
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
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 Chemistry devices follow this clearance model.

Regulatory Peers - GYB Media, Electroconductive

All 43
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K771893.
EEG GEL
K781493 · Graphic Controls Corp. · Apr 1979
CREAM, SIGNA
K782055 · Parker Laboratories, Inc. · Mar 1979
SIGNAPAD
K780973 · Parker Laboratories, Inc. · Jul 1978
CONDUCTIVE CREAM-500
K770623 · Graphic Controls Corp. · Apr 1977
CONDUCTIVITY GEL W/POTASSIUM CHLORIDE
K770622 · Graphic Controls Corp. · Apr 1977