Cleared Traditional

K790316 - ELECTRODE, ELECTROFLEX

K790316 is an FDA 510(k) clearance for ELECTRODE, manufactured by Andover Medical, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K790316 · Andover Medical, Inc. · Neurology device
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Mar 1979
Decision
40d
Days
Class 2
Risk

K790316 is an FDA 510(k) clearance for the ELECTRODE, ELECTROFLEX. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Andover Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1979 after a review of 40 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Andover Medical, Inc. devices

FDA 510(k) Submission Details - K790316

510(k) Number K790316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1979
Decision Date March 27, 1979
Days to Decision 40 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 148d · This submission: 40d
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 236
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K790316.
TRU-PULSE PADS
K800117 · Ipco Corp. · Feb 1980
MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K792351 · Medtronic Vascular · Dec 1979
T.E.N.S.* SINGLE-USE ELECTRODE
K790850 · 3M Company · May 1979
MEDTRONIC MODEL 3797 ELECTRODE
K782137 · Medtronic Vascular · Feb 1979
EEG LEAD ASSEMBLY
K781494 · Graphic Controls Corp. · Oct 1978
EAR ELECTRODE-ADULT & PEDIATRIC
K780537 · Life-Tech Instruments, Inc. · Jun 1978