Cleared Traditional

K143068 - Medical Monofilament Sensory Screening Toool

K143068 is an FDA 510(k) clearance for Medical Monofilament Sensory Screening ..., manufactured by Medical Monofilament Manufacturing. The device is a Class 1 Neurology device with product code GXB cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K143068 · Medical Monofilament Manufacturing · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
82d
Days
Class 1
Risk

K143068 is an FDA 510(k) clearance for the Medical Monofilament Sensory Screening Toool. Classified as Esthesiometer (product code GXB), Class I - General Controls.

Submitted by Medical Monofilament Manufacturing (Plymouth, US). The FDA issued a Cleared decision on January 14, 2015 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K143068

510(k) Number K143068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2014
Decision Date January 14, 2015
Days to Decision 82 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
67d faster than avg
Panel avg: 149d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

GXB Device Classification - Class 1, General Controls

Product Code GXB Esthesiometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1500
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 Consultant

AlvaMed, Inc.
Susan Hamann

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K143068 · Medical Monofilament Sensory Screening Toool
Download PDF FDA Summary Medical Monofilament …