Cleared Traditional

K900404 - VARICOSCREEN(TM) (FDA 510(k) Clearance)

Class I Radiology device.

K900404 · Promedex, Inc. · Radiology device
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Dec 1990
Decision
312d
Days
Class 1
Risk

K900404 is an FDA 510(k) clearance for the VARICOSCREEN(TM). Classified as System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use) (product code KYA), Class I - General Controls.

Submitted by Promedex, Inc. (Fort Woth, US). The FDA issued a Cleared decision on December 7, 1990 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2982 - the FDA radiology and imaging software oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Promedex, Inc. devices

Submission Details

510(k) Number K900404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date December 07, 1990
Days to Decision 312 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 107d · This submission: 312d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYA System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2982
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.