Cleared Traditional

K842483 - SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC

K842483 is the FDA 510(k) clearance for SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC by Santa Barbara Medco, Inc.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K842483 · Santa Barbara Medco, Inc. · Physical Medicine device
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Aug 1984
Decision
67d
Days
Class 2
Risk

K842483 is an FDA 510(k) clearance for the SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Santa Barbara Medco, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on August 31, 1984 after a review of 67 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 Santa Barbara Medco, Inc. devices

Submission Details

510(k) Number K842483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1984
Decision Date August 31, 1984
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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 28
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K842483.
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