Cleared Traditional

K042590 - TRANSDERM IONTO SYSTEM, MK 2

K042590 is an FDA 510(k) clearance for TRANSDERM IONTO SYSTEM, manufactured by Mattioli Engineering Corp.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K042590 · Mattioli Engineering Corp. · Physical Medicine device
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Oct 2004
Decision
21d
Days
Class 2
Risk

K042590 is an FDA 510(k) clearance for the TRANSDERM IONTO SYSTEM, MK 2. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Mattioli Engineering Corp. (Beltsville, US). The FDA issued a Cleared decision on October 14, 2004 after a review of 21 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 Mattioli Engineering Corp. devices

FDA 510(k) Submission Details - K042590

510(k) Number K042590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2004
Decision Date October 14, 2004
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 43
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K042590.
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EMPI ACTION PATCH IONTOPHORESIS SYSTEM
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DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
PHORESOR II,MODEL PM900
K982668 · Iomed, Inc. · Mar 1999