Cleared Traditional

K180627 - Macroduct Advanced Model 3710

K180627 is an FDA 510(k) clearance for Macroduct Advanced Model 3710, manufactured by Elitechgroup, Inc.. The device is a Class 2 Physical Medicine device with product code KTB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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

FDA 510(k) Submission Details - K180627

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
PCCP Authorized No
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.

KTB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KTB Device, Iontophoresis, Specific Uses

All 9
Devices cleared under the same product code (KTB) and FDA review panel - the closest regulatory comparables to K180627.
RH-950
K033192 · Iomed, Inc. · Dec 2003
RH-900
K031115 · Iomed, Inc. · Jul 2003
TRANSQ3
K001522 · Iomed, Inc. · Oct 2000
PHORESOR MODEL PM2000
K001410 · Iomed, Inc. · Aug 2000
Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
K992874 · Wr Medical Electronics Co. · Nov 1999
PHORESOR II, MODEL PM900
K974855 · Iomed, Inc. · Mar 1998