Cleared Traditional

K922752 - STARKEY LABORATORIES OTOSCOPE

K922752 is an FDA 510(k) clearance for STARKEY LABORATORIES OTOSCOPE, manufactured by Starkey Laboratories, Inc.. The device is a Class 1 Ear, Nose, Throat device with 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.

FDA 510(k) Submission Details - K922752

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
2d faster than avg
Panel avg: 90d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

ERA Device Classification - Class 1, General Controls

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 52
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K922752.
XOMED-TREACE ALPHASCOPE
K923830 · Xomed-Treace, Inc. · Nov 1992
OTO-BRITE HANDLE
K924025 · Jedmed Instrument Co. · Nov 1992
FAMILY EAR SCOPE MODEL 29001S
K923304 · Ear Care of So. Ca., Inc. · Oct 1992
OPTIEAR
K920322 · Nankivell Industries, Inc. · Apr 1992
EARBEAR OTOSCOPE
K915537 · Earbear Co. · Jan 1992
PEDIA PALS
K911650 · Pedia Pals, Inc. · Oct 1991
K922752 · STARKEY LABORATORIES OTOSCOPE
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