Cleared Traditional

K162412 - Hoggan Scientific® microFET2™

K162412 is an FDA 510(k) clearance for Hoggan Scientific microFET2, manufactured by Hoggan Scientific, LLC. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K162412 · Hoggan Scientific, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
192d
Days
Class 2
Risk

K162412 is an FDA 510(k) clearance for the Hoggan Scientific® microFET2™. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Hoggan Scientific, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 9, 2017 after a review of 192 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K162412

510(k) Number K162412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2016
Decision Date March 09, 2017
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 149d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBB Device Classification - Class 2, Special Controls

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
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 Neurology devices follow this clearance model.

Regulatory Peers - LBB Dynamometer, Ac-powered

All 32
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K162412.
FACTS HAND AND PINCH GRIP COMBO
K073154 · Global Services Group, LLC · Feb 2008
DIGITAL HAND DYNAMOMETER, MODEL SH5003
K052309 · Saehan Corp. · Sep 2005
DYNAMOMETER - MODEL FCE AND MODEL MSC
K042889 · Ametek · Nov 2004
KADANCE 2000
K012492 · Kada Research, Inc. · Nov 2001
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
K981730 · Nk Biotechnical Corp. · Jul 1998
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K980363 · Orofacial Dynamics · Apr 1998
K162412 · Hoggan Scientific® microFET2™
Download PDF FDA Summary Hoggan Scientific, LLC