Cleared Traditional

K912326 - DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS

K912326 is an FDA 510(k) clearance for DAVIS LEAD APRON - VARIOUS CATALOGUE NU..., manufactured by Davis Lead Aprons, Inc.. The device is a Class 1 Radiology device with product code KPY cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K912326 · Davis Lead Aprons, Inc. · Radiology device
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Mar 1992
Decision
299d
Days
Class 1
Risk

K912326 is an FDA 510(k) clearance for the DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS. Classified as Shield, Protective, Personnel (product code KPY), Class I - General Controls.

Submitted by Davis Lead Aprons, Inc. (Houston, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 299 days - an extended review cycle.

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 Davis Lead Aprons, Inc. devices

FDA 510(k) Submission Details - K912326

510(k) Number K912326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date March 18, 1992
Days to Decision 299 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 107d · This submission: 299d
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

All 7
Devices cleared under the same product code (KPY) and FDA review panel - the closest regulatory comparables to K912326.
INTRA-ORAL THERMOPLASTIC SHIELD
K962622 · Medtec, Inc. · Oct 1996
THERMOPLASTIC SHIELD
K954456 · Medtec, Inc. · Dec 1995
UTK-DTE AUTILARY SHIELD
K954146 · Mallinckrodt Medical · 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