Cleared Traditional

K896301 - MODEL 340 PROBE MIC SYSTEM

K896301 is an FDA 510(k) clearance for MODEL 340 PROBE MIC SYSTEM, manufactured by Virtual Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K896301 · Virtual Corp. · Ear, Nose, Throat device
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Jan 1990
Decision
78d
Days
Class 2
Risk

K896301 is an FDA 510(k) clearance for the MODEL 340 PROBE MIC SYSTEM. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Virtual Corp. (Portland, US). The FDA issued a Cleared decision on January 16, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - the FDA ear, nose and throat 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.

View all Virtual Corp. devices

FDA 510(k) Submission Details - K896301

510(k) Number K896301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date January 16, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 90d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETW Device Classification - Class 2, Special Controls

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 23
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K896301.
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
K952098 · Siemens Hearing Instruments, Inc. · May 1995
DESKREM-1000
K943459 · Starkey Laboratories, Inc. · Oct 1994
PORTAREM 2000
K943460 · Starkey Laboratories, Inc. · Oct 1994
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K884371 · Madsen Electronics (Canada) , Ltd. · Feb 1989
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K884372 · Madsen Electronics (Canada) , Ltd. · Feb 1989
AUDIOMETER
K870337 · Bio-Logic Systems Corp. · Apr 1987