Cleared Traditional

K940284 - MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION

K940284 is an FDA 510(k) clearance for MEDDEV MULTARRAY MEDICAL EXAMINING LIGH..., manufactured by Meddev International Corp.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K940284 · Meddev International Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
55d
Days
Class 1
Risk

K940284 is an FDA 510(k) clearance for the MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Meddev International Corp. (Los Altos, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meddev International Corp. devices

FDA 510(k) Submission Details - K940284

510(k) Number K940284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1994
Decision Date February 28, 1994
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 129d · This submission: 55d
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 K940284.
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CHROMOPHARE
K935832 · Berchtold Holding GmbH · Feb 1994
AC-POWERED MEDICAL EXAMINATION LIGHT
K934259 · Welch Allyn, Inc. · Jan 1994