Cleared Traditional

K073276 - IONTOPHORESIS SYSTEM

K073276 is an FDA 510(k) clearance for IONTOPHORESIS SYSTEM, manufactured by Acclarent, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K073276 · Acclarent, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
105d
Days
Class 2
Risk

K073276 is an FDA 510(k) clearance for the IONTOPHORESIS SYSTEM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on March 5, 2008 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K073276

510(k) Number K073276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2007
Decision Date March 05, 2008
Days to Decision 105 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 116d · This submission: 105d
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 72
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K073276.
ACTHYDERM
K083016 · Microlab Americas, Inc. · Jun 2009
ACTIVAPATCH
K091326 · Activatek, Inc. · May 2009
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
K080580 · Axelgaard Mfg. Co., Ltd. · Jun 2008
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · Empi · Nov 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · Empi · May 2007
MESODERM
K061849 · Aa Advanced Technology, Inc. · Apr 2007
K073276 · IONTOPHORESIS SYSTEM
Download PDF FDA Summary Acclarent, Inc.