Cleared Traditional

K934549 - ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (FDA 510(k) Clearance)

Class I Radiology device.

K934549 · Victoreen, Inc. · Radiology device
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Feb 1994
Decision
150d
Days
Class 1
Risk

K934549 is an FDA 510(k) clearance for the ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD. Classified as Holder, Syringe, Lead (product code IWR), Class I - General Controls.

Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 19, 1994 after a review of 150 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 Victoreen, Inc. devices

Submission Details

510(k) Number K934549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1993
Decision Date February 19, 1994
Days to Decision 150 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 107d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWR Holder, Syringe, Lead
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.