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.

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 181
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K933220.
GSI 60 DPOAE SYSTEM
K934658 · Lucas Grason-Stadler, Inc. · Feb 1994
SOUND SELECTOR FULL-SERVICE AUDIOMETER
K933097 · Ensoniq Corp. · Jan 1994
GLASER RT60, RT80, RT150 AUDIOMETER
K934343 · Glaser Instruments AG · Jan 1994
ORBITER 922 CLINICAL AUDIOMETER
K931324 · Madsen Electronics (Canada) , Ltd. · Nov 1993
AUDIOMETER DA 323
K933222 · Futuremed Div. of Future Impex Corp. · Nov 1993
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
K930553 · Etymotic Research · Sep 1993
K933220 · SELECTOR SL 01
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