Cleared Traditional

K961645 - MRS-2D

K961645 is an FDA 510(k) clearance for MRS-2D, manufactured by Lexicor Medical Technology, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K961645 · Lexicor Medical Technology, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
185d
Days
Class 2
Risk

K961645 is an FDA 510(k) clearance for the MRS-2D. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Lexicor Medical Technology, Inc. (Boulder, US). The FDA issued a Cleared decision on October 31, 1996 after a review of 185 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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.

View all Lexicor Medical Technology, Inc. devices

FDA 510(k) Submission Details - K961645

510(k) Number K961645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1996
Decision Date October 31, 1996
Days to Decision 185 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 148d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 53
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K961645.
MODEL ME 300 MUSCLE TESTER
K943535 · Regulatory Strategies, Inc. · Jun 1997
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
K963202 · Mega Electronics , Ltd. · May 1997
AT 62 EEG (A.K.A THE A
K965006 · Stoelting Co. · Feb 1997
DEI MODEL 20 EEG
K961718 · Discovery Engineering Intl., Inc. · Aug 1996
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
K960761 · The Prometheus Group · Aug 1996
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
K954737 · J-Tech, Inc. · Jul 1996