Cleared Traditional

K020476 - MEDION 6000

K020476 is the FDA 510(k) clearance for MEDION 6000 by Selectivemed Components, Inc.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K020476 · Selectivemed Components, Inc. · Physical Medicine device
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May 2002
Decision
80d
Days
Class 2
Risk

K020476 is an FDA 510(k) clearance for the MEDION 6000. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Selectivemed Components, Inc. (Mount Vernon, US). The FDA issued a Cleared decision on May 3, 2002 after a review of 80 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 Selectivemed Components, Inc. devices

Submission Details

510(k) Number K020476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2002
Decision Date May 03, 2002
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
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 24
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K020476.
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
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K030395 · Empi · Apr 2003
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484 · Empi · Dec 1998
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491 · Empi · May 1997