Cleared Traditional

K180627 - Macroduct Advanced Model 3710 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180627 · Elitechgroup, Inc. · Physical Medicine device
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Jul 2018
Decision
140d
Days
Class 2
Risk

K180627 is an FDA 510(k) clearance for the Macroduct Advanced Model 3710. Classified as Device, Iontophoresis, Specific Uses (product code KTB), Class II - Special Controls.

Submitted by Elitechgroup, Inc. (Logan, US). The FDA issued a Cleared decision on July 27, 2018 after a review of 140 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.

View all Elitechgroup, Inc. devices

Submission Details

510(k) Number K180627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date July 27, 2018
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTB Device, Iontophoresis, Specific 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.