Cleared Traditional

K931645 - HALUX TASKLIGHT

K931645 is an FDA 510(k) clearance for HALUX TASKLIGHT, 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 140-day FDA review.

K931645 · Burton Medical Products Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
140d
Days
Class 1
Risk

K931645 is an FDA 510(k) clearance for the HALUX TASKLIGHT. 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 August 20, 1993 after a review of 140 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 - K931645

510(k) Number K931645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date August 20, 1993
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 K931645.
RITTER MODEL 158 AND 159 EXAM LIGHTS
K932719 · Midmark Corp. · Dec 1993
VITAPEN
K924447 · Vitajet Corp. · Sep 1993
MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT
K931197 · Meddev International Corp. · Sep 1993
MI-5 DIAGNOSTIC LIGHT
K931026 · Medical Illumination, Inc. · Aug 1993
MI-4 VARIABLE SPOT LIGHT
K931646 · Medical Illumination, Inc. · Aug 1993
M.E.D. LIGHT
K925710 · Medical Illumination, Inc. · Jun 1993
K931645 · HALUX TASKLIGHT
Download PDF Burton Medical Produc…