Cleared Traditional

K943916 - VIDEOTOSCOPE

K943916 is an FDA 510(k) clearance for VIDEOTOSCOPE, 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 14-day FDA review.

K943916 · Welch Allyn, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
14d
Days
Class 1
Risk

K943916 is an FDA 510(k) clearance for the VIDEOTOSCOPE. 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 August 25, 1994 after a review of 14 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 - K943916

510(k) Number K943916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1994
Decision Date August 25, 1994
Days to Decision 14 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
76d faster than avg
Panel avg: 90d · This submission: 14d
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 54
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K943916.
HOME CARE EAR EXAMINATIO KIT
K944897 · Home Care Instruments, Inc. · Nov 1994
VIDEO OTOSCOPE
K943731 · Cuda Products Co. · Oct 1994
VIDEO SCOPE SYSTEM (OTOSCOPE)
K944031 · Jedmed Instrument Co. · Sep 1994
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
K942244 · National Custom Ent., Inc. · Jun 1994
AURAL-CAM, VIDEO EAR, VID RX
K941659 · Gracefully Yours, Inc. · Apr 1994
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE
K932259 · Clarus Medical Systems, Inc. · Dec 1993
K943916 · VIDEOTOSCOPE
Download PDF FDA Summary Welch Allyn, Inc.