Cleared Traditional

K954146 - UTK-DTE AUTILARY SHIELD

K954146 is an FDA 510(k) clearance for UTK-DTE AUTILARY SHIELD, manufactured by Mallinckrodt Medical. The device is a Class 1 Radiology device with product code KPY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K954146 · Mallinckrodt Medical · Radiology device
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Dec 1995
Decision
92d
Days
Class 1
Risk

K954146 is an FDA 510(k) clearance for the UTK-DTE AUTILARY SHIELD. Classified as Shield, Protective, Personnel (product code KPY), Class I - General Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - 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 Mallinckrodt Medical devices

FDA 510(k) Submission Details - K954146

510(k) Number K954146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date December 06, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

KPY Device Classification - Class 1, General Controls

Product Code KPY Shield, Protective, Personnel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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 - KPY Shield, Protective, Personnel

Devices cleared under the same product code (KPY) and FDA review panel - the closest regulatory comparables to K954146.
DISPOSABLE THYROID COLLAR
K110900 · Bloxr Corporation · Jun 2011
INTRA-ORAL THERMOPLASTIC SHIELD
K962622 · Medtec, Inc. · Oct 1996
THERMOPLASTIC SHIELD
K954456 · Medtec, Inc. · Dec 1995
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL
K896511 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1989
VENTIBOX
K844160 · Syncor Intl. Corp. · Dec 1984
BYPASS COIL
K811068 · G.D. Searle and Co. · May 1981