Cleared Traditional

K951005 - KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

K951005 is an FDA 510(k) clearance for KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2), manufactured by Kenex , Ltd.. The device is a Class 2 Radiology device with product code IZQ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K951005 · Kenex , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
78d
Days
Class 2
Risk

K951005 is an FDA 510(k) clearance for the KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2). Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Kenex , Ltd. (England, GB). The FDA issued a Cleared decision on May 4, 1995 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kenex , Ltd. devices

FDA 510(k) Submission Details - K951005

510(k) Number K951005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date May 04, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZQ Device Classification - Class 2, Special Controls

Product Code IZQ Injector, Contrast Medium, Automatic
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 - IZQ Injector, Contrast Medium, Automatic

All 22
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K951005.
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
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PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
K983314 · Nycomed Amersham Imaging · Feb 1999
ACIST INJECTOR SYSTEM, MODEL CL100 H
K984058 · Acist Medical Systems · Feb 1999
MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N
K760641 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976
MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N
K760643 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976