Cleared Traditional

K905518 - BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905518 · Venusa , Ltd. · Radiology device
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Jun 1991
Decision
196d
Days
Class 2
Risk

K905518 is an FDA 510(k) clearance for the BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Venusa , Ltd. (Edison, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 196 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Venusa , Ltd. devices

Submission Details

510(k) Number K905518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date June 21, 1991
Days to Decision 196 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 107d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZI System, X-ray, Angiographic

All 196
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