Cleared Traditional

K935757 - GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM

K935757 is an FDA 510(k) clearance for GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM, manufactured by Greenleaf Medical Systems, Inc.. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K935757 · Greenleaf Medical Systems, Inc. · Neurology device
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Apr 1994
Decision
140d
Days
Class 2
Risk

K935757 is an FDA 510(k) clearance for the GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Greenleaf Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 140 days - within the typical 510(k) review window.

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.

View all Greenleaf Medical Systems, Inc. devices

FDA 510(k) Submission Details - K935757

510(k) Number K935757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date April 15, 1994
Days to Decision 140 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 148d · This submission: 140d
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 12
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K935757.
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K980363 · Orofacial Dynamics · Apr 1998
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K964933 · Mekanika, Inc. · Feb 1997
DYNAMOMETER
K964685 · John Chatillon & Sons, Inc. · Jan 1997
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K901290 · Chattanooga Group, Inc. · Oct 1990
KIN-COM JR
K881388 · Chattanooga Group, Inc. · Apr 1988
DIGITAL GRIP/PINCH STRENGTH METOR
K850697 · Chattanooga Group, Inc. · May 1985