Cleared Traditional

K921493 - LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100

K921493 is an FDA 510(k) clearance for LS100 HALOGEN EXAMINATION LIGHT, 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 218-day FDA review.

K921493 · Welch Allyn, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
218d
Days
Class 1
Risk

K921493 is an FDA 510(k) clearance for the LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100. 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 November 3, 1992 after a review of 218 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.

FDA 510(k) Submission Details - K921493

510(k) Number K921493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date November 03, 1992
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
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 K921493.
ILLUMINATOR II
K922277 · Medical Illumination, Inc. · Feb 1993
ILLUMINATOR VII MINI/LUM LIGHT
K922280 · Medical Illumination, Inc. · Feb 1993
ILLUMINATOR VII MINI/SPOT LIGHT
K922281 · Medical Illumination, Inc. · Feb 1993
EXAMINATION LAMP
K922150 · Air-Shields, Inc. · Jul 1992
EPISCOPE, MODEL 47300
K920103 · Welch Allyn, Inc. · Apr 1992
LIGHT, HEAD, EXAMINATION
K901706 · Burton Medical Products Corp. · Jul 1990
K921493 · LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
Download PDF Welch Allyn, Inc.