Cleared Traditional

K960500 - THE VIRTUAL M-332

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.

FDA 510(k) Submission Details - K960500

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

29d faster than avg

Panel avg: 90d · This submission: 61d

Pathway characteristics

Predicate-based equivalence.

EWD Device Classification - Class 0,

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

Regulatory Peers - EWD Protector, Hearing (insert)

All 13

Devices cleared under the same product code (EWD) and FDA review panel - the closest regulatory comparables to K960500.

SUPER SILIPLUGS EAR PLUGS

K972923 · Interview Medical Technology Corp. · Oct 1997

SILICONE PUTTY EAR PLUGS

K971517 · Bentec Medical, Inc. · Jun 1997

HEARSAVER

K962292 · Emtech Laboratories · Oct 1996

DOC'S PROPLUGS EAR PLUGS

K945376 · Doc'S Proplugs, Inc. · Nov 1995

MODEL 322 CLINICAL AUDIOMETER

K930203 · Virtual Corp. · Jul 1993

#903 SILAFLEX II

K915739 · Flents Products Co., Inc. · Jun 1992

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K960500

Virtual Corp.

Portland, OR · US

JONATHAN D BIRCK

Regulatory profile

9 submissions 9 cleared

100% clearance rate · Active in Ear, Nose, Throat

View all devices by Virtual Corp. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: April 3, 1996. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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