Cleared Traditional

K905447 - E-Z-EM PULSED INFUSION SYSTEM

K905447 is the FDA 510(k) clearance for E-Z-EM PULSED INFUSION SYSTEM by E-Z-Em, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K905447 · E-Z-Em, Inc. · Cardiovascular device
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Apr 1991
Decision
117d
Days
Class 2
Risk

K905447 is an FDA 510(k) clearance for the E-Z-EM PULSED INFUSION SYSTEM. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Worcester, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K905447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date April 01, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 128
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K905447.
SELECTIVE INFUSION II CATHETER
K914751 · Advanced Cardiovascular Systems, Inc. · May 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993
MAGIC INFUSION CATHETER
K923368 · Target Therapeutics · Apr 1993
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · Baxter Healthcare Corp · Jan 1990
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K885281 · Baxter Healthcare Corp · Mar 1989
JEHLE CORONARY PERFUSION CATHETERS
K884946 · Pilling Co. · Feb 1989