Cleared Traditional

K895365 - MD-2 IONTOPHORESIS UNIT

K895365 is an FDA 510(k) clearance for MD-2 IONTOPHORESIS UNIT, manufactured by R. A. Fischer Co. Corp.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K895365

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.

EGJ Device Classification - Class 2, Special Controls

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 57
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
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TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K912014 · Empi · Oct 1991
IONTOPHORESIS DEVICE
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DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
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