Cleared Traditional

K850918 - TYPE FP30 DIGITAL HEARING AID ANALYZER

K850918 is an FDA 510(k) clearance for TYPE FP30 DIGITAL 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 85-day FDA review.

K850918 · Frye Electronics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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May 1985
Decision
85d
Days
Class 2
Risk

K850918 is an FDA 510(k) clearance for the TYPE FP30 DIGITAL 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 May 29, 1985 after a review of 85 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 Frye Electronics, Inc. devices

FDA 510(k) Submission Details - K850918

510(k) Number K850918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date May 29, 1985
Days to Decision 85 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
5d faster than avg
Panel avg: 90d · This submission: 85d
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 20
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K850918.
PHONIC EAR
K861857 · Phonic Ear, Inc. · Jun 1986
INSERTION GAIN OPTIMIZER IGO-1000
K854535 · Madsen Electronics (Canada) , Ltd. · Feb 1986
HEARING AID ANALYSIS SYSTEM
K853271 · Robert Bosch Corp. · Jan 1986
STARKET MODEL HMS
K844275 · Starkey Laboratories, Inc. · Dec 1984
STARKEY MODEL HAL-1
K821908 · Starkey Laboratories, Inc. · Aug 1982