Cleared Traditional

K010981 - GSA GENITO SENSORY ANALYZER

K010981 is an FDA 510(k) clearance for GSA GENITO SENSORY ANALYZER, manufactured by Medoc Ltd. Advanced Medical Systems. The device is a Class 1 Neurology device with product code LLN cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K010981 · Medoc Ltd. Advanced Medical Systems · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
171d
Days
Class 1
Risk

K010981 is an FDA 510(k) clearance for the GSA GENITO SENSORY ANALYZER. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Medoc Ltd. Advanced Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on September 20, 2001 after a review of 171 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - 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 - K010981

510(k) Number K010981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2001
Decision Date September 20, 2001
Days to Decision 171 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
22d slower than avg
Panel avg: 149d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

LLN Device Classification - Class 1, General Controls

Product Code LLN Device, Vibration Threshold Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LLN Device, Vibration Threshold Measurement

All 12
Devices cleared under the same product code (LLN) and FDA review panel - the closest regulatory comparables to K010981.
PAIN VISION, MODEL PS-2100
K072882 · Osachi Co., Ltd. · Jan 2009
VPT METER
K030829 · Xilas Medical, Inc. · Dec 2003
MEDI-DX 7000
K964622 · Neuro-Diagnostic Assoc. · Dec 1997
AP-4000, AIR PULSE SENSORY STIMULATOR
K964815 · Pentax Precision Instrument Corp. · Sep 1997
VSA 3000 VIBRATORYN SENSORY ANALYZER
K970180 · Eare Consulting Service · Apr 1997
NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001
K934368 · Nk Biotechnical Engineering Co. · Aug 1994
K010981 · GSA GENITO SENSORY ANALYZER
Download PDF FDA Summary Medoc Ltd. Advanced M…