Cleared Traditional

K940119 - ROYAL MARSDEN GOLD GRAIN GUN (FDA 510(k) Clearance)

Class I Radiology device.

K940119 · Best Industries · Radiology device
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Dec 1994
Decision
354d
Days
Class 1
Risk

K940119 is an FDA 510(k) clearance for the ROYAL MARSDEN GOLD GRAIN GUN. Classified as Shield, Eye, Radiological (product code IWS), Class I - General Controls.

Submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on December 30, 1994 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.

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Submission Details

510(k) Number K940119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date December 30, 1994
Days to Decision 354 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 107d · This submission: 354d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.