Cleared Traditional

K832601 - LEADED X-RAY APRON (FDA 510(k) Clearance)

Class I Radiology device.

K832601 · E.M. Adams · Radiology device
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Sep 1983
Decision
58d
Days
Class 1
Risk

K832601 is an FDA 510(k) clearance for the LEADED X-RAY APRON. Classified as Apron, Leaded (product code EAJ), Class I - General Controls.

Submitted by E.M. Adams (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 58 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 E.M. Adams devices

Submission Details

510(k) Number K832601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date September 29, 1983
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
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.