Cleared Traditional

K900197 - THE MAX SYSTEM

K900197 is an FDA 510(k) clearance for THE MAX SYSTEM, manufactured by Sound Linked Data, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K900197 · Sound Linked Data, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
456d
Days
Class 2
Risk

K900197 is an FDA 510(k) clearance for the THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Sound Linked Data, Inc. (Canada L4w 2tf, CA). The FDA issued a Cleared decision on April 17, 1991 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Sound Linked Data, Inc. devices

FDA 510(k) Submission Details - K900197

510(k) Number K900197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date April 17, 1991
Days to Decision 456 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
367d slower than avg
Panel avg: 89d · This submission: 456d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K900197.
THE BELTONE AUDIO SCOUT
K915323 · Beltone Electronics Corp. · May 1992
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669 · Resound Corp. · Sep 1991
MAICO MA800 AUDIOMETER
K911368 · Maico Hearing Instruments, Inc. · Jun 1991
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544 · Qualitone · Oct 1990
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · Starkey Laboratories, Inc. · Aug 1990
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · Maico Hearing Instruments, Inc. · Jan 1990