Cleared Traditional

K895365 - MD-2 IONTOPHORESIS UNIT

K895365 is the FDA 510(k) clearance for MD-2 IONTOPHORESIS UNIT by R. A. Fischer Co. Corp.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K895365 · R. A. Fischer Co. Corp. · Physical Medicine device
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Jun 1990
Decision
302d
Days
Class 2
Risk

K895365 is an FDA 510(k) clearance for the MD-2 IONTOPHORESIS UNIT. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by R. A. Fischer Co. Corp. (Glendale, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all R. A. Fischer Co. Corp. devices

Submission Details

510(k) Number K895365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received August 28, 1989
Decision Date June 26, 1990
Days to Decision 302 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
187d slower than avg
Panel avg: 115d · This submission: 302d
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 27
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K895365.
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K912015 · Empi · Nov 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K912014 · Empi · Oct 1991
IONTOPHORESIS DEVICE
K903093 · Empi · Oct 1990
TBD IONTOPHORESIS ELECTRODE
K896703 · Empi · Feb 1990
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549 · Henley Intl. · Feb 1990
XOMED IONESTHETIZER(TM)
K884834 · Xomed, Inc. · Feb 1989