Cleared Traditional

K952578 - WELCH ALLY OTOSCOPE

K952578 is an FDA 510(k) clearance for WELCH ALLY OTOSCOPE, manufactured by Welch Allyn, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K952578 · Welch Allyn, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
35d
Days
Class 1
Risk

K952578 is an FDA 510(k) clearance for the WELCH ALLY OTOSCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 10, 1995 after a review of 35 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 Welch Allyn, Inc. devices

FDA 510(k) Submission Details - K952578

510(k) Number K952578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date July 10, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 90d · This submission: 35d
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 36
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K952578.
OSRAM ITOS
K110326 · Osram Sylvania, Inc. · Oct 2011
OPTUS OTOSCOPES
K945264 · Optus, Inc. · Feb 1996
WELCH ALLYN BI-OTOSCOPE
K955043 · Welch Allyn, Inc. · Nov 1995
PERFECT, ENT SET, PRAKTIKANT, DE LUXE
K950913 · Rudolf Riester GmbH & Co. KG · May 1995
OTOSCOPE A-34
K950788 · Neitz Instruments Company, Ltd. · May 1995
WELCH ALLYN OTOSCOPE
K950787 · Welch Allyn, Inc. · Apr 1995