Cleared Traditional

K854535 - INSERTION GAIN OPTIMIZER IGO-1000

K854535 is the FDA 510(k) clearance for INSERTION GAIN OPTIMIZER IGO-1000 by Madsen Electronics (Canada) , Ltd.. It is a Class 2 Ear, Nose, Throat device (product code ETW) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K854535 · Madsen Electronics (Canada) , Ltd. · Ear, Nose, Throat device
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Feb 1986
Decision
99d
Days
Class 2
Risk

K854535 is an FDA 510(k) clearance for the INSERTION GAIN OPTIMIZER IGO-1000. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on February 20, 1986 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Madsen Electronics (Canada) , Ltd. devices

Submission Details

510(k) Number K854535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date February 20, 1986
Days to Decision 99 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
10d slower than avg
Panel avg: 89d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K854535.
AUDIOMETER
K870337 · Bio-Logic Systems Corp. · Apr 1987
PHONIC EAR, MODEL PE 1800
K862162 · Phonic Ear, Inc. · Jul 1986
PHONIC EAR
K861857 · Phonic Ear, Inc. · Jun 1986
STARKET MODEL HMS
K844275 · Starkey Laboratories, Inc. · Dec 1984
STARKEY MODEL HAL-1
K821908 · Starkey Laboratories, Inc. · Aug 1982