Cleared Traditional

K933222 - AUDIOMETER DA 323

K933222 is an FDA 510(k) clearance for AUDIOMETER DA 323, manufactured by Futuremed Div. of Future Impex Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K933222 · Futuremed Div. of Future Impex Corp. · Ear, Nose, Throat device
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Nov 1993
Decision
123d
Days
Class 2
Risk

K933222 is an FDA 510(k) clearance for the AUDIOMETER DA 323. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Futuremed Div. of Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on November 1, 1993 after a review of 123 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K933222

510(k) Number K933222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date November 01, 1993
Days to Decision 123 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
33d slower than avg
Panel avg: 90d · This submission: 123d
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 181
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K933222.
GLASER RT60, RT80, RT150 AUDIOMETER
K934343 · Glaser Instruments AG · Jan 1994
SELECTOR SL 01
K933220 · Futuremed Div. of Future Impex Corp. · Nov 1993
ORBITER 922 CLINICAL AUDIOMETER
K931324 · Madsen Electronics (Canada) , Ltd. · Nov 1993
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
K930553 · Etymotic Research · Sep 1993
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · Maico Hearing Instruments, Inc. · Aug 1993
MAICO MA790 AUDIOMETER
K930112 · Maico Hearing Instruments, Inc. · Aug 1993
K933222 · AUDIOMETER DA 323
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