Cleared Traditional

K032968 - TRSANSDERM IONTO SYSTEM

K032968 is an FDA 510(k) clearance for TRSANSDERM 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 70-day FDA review.

K032968 · Mattioli Engineering Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
70d
Days
Class 2
Risk

K032968 is an FDA 510(k) clearance for the TRSANSDERM IONTO SYSTEM. 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 December 2, 2003 after a review of 70 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.

FDA 510(k) Submission Details - K032968

510(k) Number K032968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2003
Decision Date December 02, 2003
Days to Decision 70 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 116d · This submission: 70d
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 67
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K032968.
TRANSDERM IONTO SYSTEM, MK 2
K042590 · Mattioli Engineering Corp. · Oct 2004
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
K041101 · Medical Adhesiveonline, LLC · Jul 2004
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
K040495 · Naimco, Inc. · Apr 2004
E-STRIP
K031769 · Eemso, Inc. · Oct 2003
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
K031053 · Selectivemed Components, Inc. · May 2003
MINIPHYSIONIZER 2.0 AND ELECTRODES
K022950 · Physion, Inc. · Apr 2003
K032968 · TRSANSDERM IONTO SYSTEM
Download PDF FDA Summary Mattioli Engineering …