Cleared Traditional

K900404 - VARICOSCREEN(TM)

K900404 is an FDA 510(k) clearance for VARICOSCREEN(TM), manufactured by Promedex, Inc.. The device is a Class 1 Radiology device with product code KYA cleared through the Traditional 510(k) pathway after a 312-day FDA review.

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

FDA 510(k) Submission Details - K900404

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.

KYA Device Classification - Class 1, General Controls

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.