Cleared Traditional

DZIDRA GLASS FOR USE IN NEUROLOGY (K864678) - FDA 510(k) Clearance

K864678 · Glen Whitten, Dds · Neurology device
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Feb 1987
Decision
85d
Days
-
Risk

K864678 is an FDA 510(k) clearance for the DZIDRA GLASS FOR USE IN NEUROLOGY.

Submitted by Glen Whitten, Dds (Lakeland, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel. 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.

View all Glen Whitten, Dds devices

Submission Details

510(k) Number K864678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date February 25, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -