Cleared Traditional

K945515 - COATED TUNGSTEN EYESHIELD

K945515 is an FDA 510(k) clearance for COATED TUNGSTEN EYESHIELD, manufactured by Medtec, Inc.. The device is a Class 1 Radiology device with product code IWS cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K945515 · Medtec, Inc. · Radiology device
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Jun 1995
Decision
222d
Days
Class 1
Risk

K945515 is an FDA 510(k) clearance for the COATED TUNGSTEN EYESHIELD. Classified as Shield, Eye, Radiological (product code IWS), Class I - General Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on June 19, 1995 after a review of 222 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - 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. Standard predicate reliance. 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 Medtec, Inc. devices

FDA 510(k) Submission Details - K945515

510(k) Number K945515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date June 19, 1995
Days to Decision 222 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 107d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

IWS Device Classification - Class 1, General Controls

Product Code IWS Shield, Eye, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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.