Cleared Traditional

K950787 - WELCH ALLYN OTOSCOPE

K950787 is an FDA 510(k) clearance for WELCH ALLYN 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 44-day FDA review.

K950787 · Welch Allyn, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
44d
Days
Class 1
Risk

K950787 is an FDA 510(k) clearance for the WELCH ALLYN 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 April 6, 1995 after a review of 44 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 - K950787

510(k) Number K950787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date April 06, 1995
Days to Decision 44 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
46d faster than avg
Panel avg: 90d · This submission: 44d
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 K950787.
WELCH ALLY OTOSCOPE
K952578 · Welch Allyn, Inc. · Jul 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
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
K946043 · Rudolf Riester GmbH & Co. KG · Mar 1995
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · Smith & Nephew, Inc. · Nov 1994
VIDEO OTOSCOPE
K943731 · Cuda Products Co. · Oct 1994