Cleared Traditional

K953884 - PROPHET

K953884 is an FDA 510(k) clearance for PROPHET, manufactured by Qualitone. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K953884 · Qualitone · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
71d
Days
Class 2
Risk

K953884 is an FDA 510(k) clearance for the PROPHET. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Qualitone (Minneapolis, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 71 days - a notably fast clearance cycle.

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: 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 Qualitone devices

FDA 510(k) Submission Details - K953884

510(k) Number K953884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1995
Decision Date October 27, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 90d · This submission: 71d
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 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K953884.
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
K962012 · Ethical Hearing Instruments · Aug 1996
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
K961447 · Bio-Logic Systems Corp. · May 1996
GSI 61 CLINICAL AUDIOMETER
K953684 · Grason-Stadler, Inc. · Oct 1995
BELTONE PERSONAL HEARING SCREENER
K943616 · Beltone Electronics Corp. · Jul 1995
GSI 65 COMPUTERIZED AUDIOMETER
K951759 · Grason-Stadler, Inc. · Jul 1995
THE PILOT AUDIOMETER
K951527 · American Electromedics Corp. · May 1995