Cleared Traditional

K852160 - RADIOLOGICAL MARKING PEN

K852160 is an FDA 510(k) clearance for RADIOLOGICAL MARKING PEN, manufactured by Truett Laboratories, Inc.. The device is a Class 1 Radiology device with product code JAC cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K852160 · Truett Laboratories, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K852160

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.

JAC Device Classification - Class 1, General Controls

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.