Cleared Traditional

K852160 - RADIOLOGICAL MARKING PEN (FDA 510(k) Clearance)

Class I Radiology device.

K852160 · Truett Laboratories, Inc. · Radiology device
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Jul 1985
Decision
140d
Days
Class 1
Risk

K852160 is an FDA 510(k) clearance for the RADIOLOGICAL MARKING PEN. Classified as System, X-ray, Film Marking, Radiographic (product code JAC), Class I - General Controls.

Submitted by Truett Laboratories, Inc. (Azusa, US). The FDA issued a Cleared decision on July 18, 1985 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1640 - 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 Truett Laboratories, Inc. devices

Submission Details

510(k) Number K852160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1985
Decision Date July 18, 1985
Days to Decision 140 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAC System, X-ray, Film Marking, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1640
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.