Cleared Traditional

K933564 - SKYTRON EXAM LIGHT

K933564 is an FDA 510(k) clearance for SKYTRON EXAM LIGHT, manufactured by Skytron, Div. the Kmw Group, Inc.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K933564 · Skytron, Div. the Kmw Group, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
203d
Days
Class 1
Risk

K933564 is an FDA 510(k) clearance for the SKYTRON EXAM LIGHT. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 203 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 - K933564

510(k) Number K933564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date February 10, 1994
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
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 36
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K933564.
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
CHROMOPHARE
K935832 · Berchtold Holding GmbH · Feb 1994
AC-POWERED MEDICAL EXAMINATION LIGHT
K934259 · Welch Allyn, Inc. · Jan 1994
RITTER MODEL 158 AND 159 EXAM LIGHTS
K932719 · Midmark Corp. · Dec 1993
K933564 · SKYTRON EXAM LIGHT
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