Cleared Traditional

K933220 - SELECTOR SL 01

K933220 is an FDA 510(k) clearance for SELECTOR SL 01, 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 146-day FDA review.

K933220 · Futuremed Div. of Future Impex Corp. · Ear, Nose, Throat device
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Nov 1993
Decision
146d
Days
Class 2
Risk

K933220 is an FDA 510(k) clearance for the SELECTOR SL 01. 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 24, 1993 after a review of 146 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.

View all Futuremed Div. of Future Impex Corp. devices

FDA 510(k) Submission Details - K933220

510(k) Number K933220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date November 24, 1993
Days to Decision 146 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
56d slower than avg
Panel avg: 90d · This submission: 146d
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 76
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K933220.
BELTONE SERIES 100 AUDIOMETERS
K940216 · Beltone Electronics Corp. · Jul 1994
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
K931325 · Madsen Electronics (Canada) , Ltd. · Feb 1994
ODYSSEY CLINICAL AUDIOMETER
K935348 · Qualitone · Feb 1994
ORBITER 922 CLINICAL AUDIOMETER
K931324 · Madsen Electronics (Canada) , Ltd. · Nov 1993
AUDIOMETER DA 323
K933222 · Futuremed Div. of Future Impex Corp. · Nov 1993
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · Maico Hearing Instruments, Inc. · Aug 1993