Cleared Traditional

K831320 - DRIONIC

K831320 is the FDA 510(k) clearance for DRIONIC by General Medical Co.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K831320 · General Medical Co. · Physical Medicine device
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Jul 1983
Decision
88d
Days
Class 2
Risk

K831320 is an FDA 510(k) clearance for the DRIONIC. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by General Medical Co. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine 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 General Medical Co. devices

Submission Details

510(k) Number K831320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1983
Decision Date July 19, 1983
Days to Decision 88 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 9
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K831320.
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K170835 · Hightech Development · Jun 2018
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015
XOMED IONESTHETIZER(TM)
K884834 · Xomed, Inc. · Feb 1989
IONTOPHORESIS SYSTEM MODULE, DM 500
K770717 · Sorensen Research · Aug 1977