Cleared Traditional

K934549 - ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD

K934549 is an FDA 510(k) clearance for ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD, manufactured by Victoreen, Inc.. The device is a Class 1 Radiology device with product code IWR cleared through the Traditional 510(k) pathway after a 150-day FDA review.

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

FDA 510(k) Submission Details - K934549

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 107d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

IWR Device Classification - Class 1, General Controls

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.