Cleared Traditional

K936088 - WAVE FLUORESCENT MAGNIFIER

K936088 is an FDA 510(k) clearance for WAVE FLUORESCENT MAGNIFIER, 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 126-day FDA review.

K936088 · Burton Medical Products Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
126d
Days
Class 1
Risk

K936088 is an FDA 510(k) clearance for the WAVE FLUORESCENT MAGNIFIER. 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 April 26, 1994 after a review of 126 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 - K936088

510(k) Number K936088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1993
Decision Date April 26, 1994
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
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 K936088.
NEVOSCOPE
K954943 · Nizar A. Mullani · Mar 1996
WELCH ALLYN VIDEO EPISCOPE
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H 5100, H 5200, H 5300
K945507 · Rudolf Riester GmbH & Co. KG · Dec 1994
SKYTRON EXAM LIGHT
K933564 · Skytron, Div. the Kmw Group, Inc. · Feb 1994
CHROMOPHARE
K935832 · Berchtold Holding GmbH · Feb 1994
AC-POWERED MEDICAL EXAMINATION LIGHT
K934259 · Welch Allyn, Inc. · Jan 1994