Cleared Traditional

K935400 - FONIX 3500 HEARING AID ANALYZER

K935400 is an FDA 510(k) clearance for FONIX 3500 HEARING AID ANALYZER, manufactured by Frye Electronics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K935400 · Frye Electronics, Inc. · Ear, Nose, Throat device
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Jan 1994
Decision
66d
Days
Class 2
Risk

K935400 is an FDA 510(k) clearance for the FONIX 3500 HEARING AID ANALYZER. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on January 14, 1994 after a review of 66 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.

FDA 510(k) Submission Details - K935400

510(k) Number K935400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date January 14, 1994
Days to Decision 66 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
24d faster than avg
Panel avg: 90d · This submission: 66d
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 42
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K935400.
INTERACOUSTICS HEARING AID ANALYZER MS 40
K943607 · Precision Acoustics Ind., Inc. · Sep 1994
INTERACOUSTICS. HEARING AID ANALYZER
K941848 · Precision Acoustics Ind., Inc. · May 1994
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
K934342 · Glaser Instruments AG · Jan 1994
RASTRONICS CCI 8
K902244 · Rastronics USA, Inc. · Oct 1990
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
K902252 · Rastronics USA, Inc. · Sep 1990
CAS (COMPUTERIZED ANALYZER SYSTEM)
K896996 · Gn Danavox, Inc. · Aug 1990
K935400 · FONIX 3500 HEARING AID ANALYZER
Download PDF Frye Electronics, Inc.