Cleared Traditional

K913621 - RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR (FDA 510(k) Clearance)

Class I Radiology device.

K913621 · Rinn Dental Products · Radiology device
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Sep 1991
Decision
45d
Days
Class 1
Risk

K913621 is an FDA 510(k) clearance for the RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR. Classified as Apron, Leaded (product code EAJ), Class I - General Controls.

Submitted by Rinn Dental Products (Elgin, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 45 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 Rinn Dental Products devices

Submission Details

510(k) Number K913621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date September 27, 1991
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
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.