Cleared Traditional

K924313 - DIGITAL CONDUCTANCE METER

K924313 is an FDA 510(k) clearance for DIGITAL CONDUCTANCE METER, manufactured by The Jayms Co.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 1296-day FDA review.

K924313 · The Jayms Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
1296d
Days
Class 2
Risk

K924313 is an FDA 510(k) clearance for the DIGITAL CONDUCTANCE METER. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by The Jayms Co. (Lindon, US). The FDA issued a Cleared decision on March 14, 1996 after a review of 1296 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all The Jayms Co. devices

FDA 510(k) Submission Details - K924313

510(k) Number K924313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1992
Decision Date March 14, 1996
Days to Decision 1296 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
1148d slower than avg
Panel avg: 148d · This submission: 1296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 42
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K924313.
AT 62 EEG (A.K.A THE A
K965006 · Stoelting Co. · Feb 1997
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
K954737 · J-Tech, Inc. · Jul 1996
AT53 DUAL CHANNEL EMG
K952797 · Stoelting Co. · Apr 1996
ORALSENSOR
K953257 · Cycura Corp. · Feb 1996
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995
MYOTRAC2
K915858 · Thought Technology , Ltd. · Sep 1992