Cleared Traditional

K934259 - AC-POWERED MEDICAL EXAMINATION LIGHT

K934259 is the FDA 510(k) clearance for AC-POWERED MEDICAL EXAMINATION LIGHT by Welch Allyn, Inc.. It is a Class 1 General Hospital device (product code KZF) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K934259 · Welch Allyn, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
150d
Days
Class 1
Risk

K934259 is an FDA 510(k) clearance for the AC-POWERED MEDICAL EXAMINATION LIGHT. 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 January 28, 1994 after a review of 150 days - an extended review cycle.

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.

View all Welch Allyn, Inc. devices

Submission Details

510(k) Number K934259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date January 28, 1994
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 8
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K934259.
WELCH ALLYN VIDEO EPISCOPE
K952835 · Welch Allyn, Inc. · Sep 1995
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
K921493 · Welch Allyn, Inc. · Nov 1992
EPISCOPE, MODEL 47300
K920103 · Welch Allyn, Inc. · Apr 1992
OLYMPIC LIGHT-WARM
K896611 · Olympic Medical Corp. · Feb 1990
TINY HALOGEN EXAM LIGHT
K896962 · Jedmed Instrument Co. · Dec 1989
WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST
K852949 · Welch Allyn, Inc. · Sep 1985