Cleared Traditional

K901706 - LIGHT, HEAD, EXAMINATION

K901706 is an FDA 510(k) clearance for LIGHT, manufactured by Burton Medical Products Corp.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K901706 · Burton Medical Products Corp. · General Hospital
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Jul 1990
Decision
98d
Days
Class 1
Risk

K901706 is an FDA 510(k) clearance for the LIGHT, HEAD, EXAMINATION. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on July 19, 1990 after a review of 98 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.

View all Burton Medical Products Corp. devices

FDA 510(k) Submission Details - K901706

510(k) Number K901706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1990
Decision Date July 19, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
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 15
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K901706.
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
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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