Cleared Traditional

K922752 - STARKEY LABORATORIES OTOSCOPE

K922752 is the FDA 510(k) clearance for STARKEY LABORATORIES OTOSCOPE by Starkey Laboratories, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ERA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K922752 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Sep 1992
Decision
88d
Days
Class 1
Risk

K922752 is an FDA 510(k) clearance for the STARKEY LABORATORIES OTOSCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4770 - 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 Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K922752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date September 04, 1992
Days to Decision 88 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
1d faster than avg
Panel avg: 89d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ERA Otoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ERA Otoscope

All 20
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K922752.
VIDEO SCOPE SYSTEM (OTOSCOPE)
K944031 · Jedmed Instrument Co. · Sep 1994
VIDEOTOSCOPE
K943916 · Welch Allyn, Inc. · Aug 1994
OTO-BRITE HANDLE
K924025 · Jedmed Instrument Co. · Nov 1992
VIDEO OTOSCOPE
K904802 · Jedmed Instrument Co. · Jan 1991
TYMPANOSCOPE
K896274 · Jedmed Instrument Co. · Jan 1990
I22 INITIALES
K862621 · Oticon Corp. · Aug 1986