Cleared Traditional

K964782 - MEDRAD CONTRAST HOLDER

K964782 is the FDA 510(k) clearance for MEDRAD CONTRAST HOLDER by Medrad, Inc.. It is a Class 1 General Hospital device (product code FOX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K964782 · Medrad, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
90d
Days
Class 1
Risk

K964782 is an FDA 510(k) clearance for the MEDRAD CONTRAST HOLDER. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on February 25, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6990 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

Submission Details

510(k) Number K964782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date February 25, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOX Stand, Infusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6990
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.

Regulatory Peers - FOX Stand, Infusion

Devices cleared under the same product code (FOX) and FDA review panel - the closest regulatory comparables to K964782.
STAND, INFUSION
K946201 · Medical Specialties, Inc. · Apr 1995
FLEXSYS MOBILEMATE EQUIPMENT STAND
K944580 · Hill-Rom, Inc. · Mar 1995
HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER
K883133 · Ferguson Medical · Nov 1988
POLE, INTRAVENOUS
K880537 · Ferguson Medical · Apr 1988
TRACK AND CARRIER, INTRAVENOUS
K880538 · Ferguson Medical · Feb 1988
CATHETER, SURFLO, I.V.
K770422 · Terumo America, Inc. · Mar 1977