Cleared Traditional

K905819 - MEDRAD VARIBLE INFUSION INJECTOR (FDA 510(k) Clearance)

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

K905819 · Medrad, Inc. · Radiology device
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Sep 1991
Decision
259d
Days
Class 2
Risk

K905819 is an FDA 510(k) clearance for the MEDRAD VARIBLE INFUSION INJECTOR. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 259 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1650 - 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 Medrad, Inc. devices

Submission Details

510(k) Number K905819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1990
Decision Date September 16, 1991
Days to Decision 259 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 107d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 206
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K905819.
High Pressure Syringe
K253048 · Shenzhen Maiwei Biotech Co., Ltd. · Apr 2026
Extension tube
K251788 · Zhuhai DR Medical Instruments Co., Ltd. · Mar 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K252891 · Bayer Medical Care, Inc. · Feb 2026
High Pressure Tubing
K244038 · Shandong Int Medical Instruments Co., Ltd. · Sep 2025
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
Disposable Syringe (Kit)
K242212 · Nemoto Kyorindo Co., Ltd. · Aug 2024