Cleared Traditional

K931269 - LEAD APRON (FDA 510(k) Clearance)

Class I Radiology device.

K931269 · Bt Medical Co., Inc. · Radiology device
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Jun 1993
Decision
86d
Days
Class 1
Risk

K931269 is an FDA 510(k) clearance for the LEAD APRON. Classified as Apron, Leaded (product code EAJ), Class I - General Controls.

Submitted by Bt Medical Co., Inc. (Bridgeport, US). The FDA issued a Cleared decision on June 2, 1993 after a review of 86 days - a notably fast clearance 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: 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 Bt Medical Co., Inc. devices

Submission Details

510(k) Number K931269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date June 02, 1993
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAJ Apron, Leaded
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.