Cleared Traditional

THE VIRTUAL M-332 (K960500) - FDA 510(k) Clearance

K960500 · Virtual Corp. · Ear, Nose, Throat device
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Apr 1996
Decision
61d
Days
-
Risk

K960500 is an FDA 510(k) clearance for the THE VIRTUAL M-332. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Virtual Corp. (Portland, US). The FDA issued a Cleared decision on April 3, 1996 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat 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 Virtual Corp. devices

Submission Details

510(k) Number K960500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1996
Decision Date April 03, 1996
Days to Decision 61 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 89d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -