Cleared Traditional

K952835 - WELCH ALLYN VIDEO EPISCOPE

K952835 is an FDA 510(k) clearance for WELCH ALLYN VIDEO EPISCOPE, manufactured by Welch Allyn, Inc.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K952835 · Welch Allyn, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
94d
Days
Class 1
Risk

K952835 is an FDA 510(k) clearance for the WELCH ALLYN VIDEO EPISCOPE. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on September 22, 1995 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K952835

510(k) Number K952835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1995
Decision Date September 22, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

KZF Device Classification - Class 1, General Controls

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
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 - KZF Device, Medical Examination, Ac Powered

All 35
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K952835.
NEVOSCOPE
K954943 · Nizar A. Mullani · Mar 1996
H 5100, H 5200, H 5300
K945507 · Rudolf Riester GmbH & Co. KG · Dec 1994
SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG
K941869 · The Lighthouse For the Blind, Inc. · Aug 1994
WAVE FLUORESCENT MAGNIFIER
K936088 · Burton Medical Products Corp. · Apr 1994
MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION
K940284 · Meddev International Corp. · Feb 1994
SKYTRON EXAM LIGHT
K933564 · Skytron, Div. the Kmw Group, Inc. · Feb 1994
K952835 · WELCH ALLYN VIDEO EPISCOPE
Download PDF FDA Summary Welch Allyn, Inc.