510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852160Substantially Equivalent

Radiological Marking Pen

Truett Laboratories, Inc., Azusa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852160 is the FDA 510(k) clearance record for RADIOLOGICAL MARKING PEN, a class I device, cleared for Truett Laboratories, Inc. on under FDA product code JAC (System, X-Ray, Film Marking, Radiographic). FDA records list one 510(k) clearance for Truett Laboratories, Inc. As of , FDA records show no recalls naming K852160.

Clearance record

Decision date
Received
(140 days to decision)
Product code
JAC System, X-Ray, Film Marking, Radiographic
Regulation
21 CFR 892.1640
Device class
Class I
Review panel
Radiology
Applicant
Truett Laboratories, Inc. 798 N. Coney Ave., Azusa CA
Third party review
No

Clearances, product code JAC

Trailing 12 months

FDA records hold no clearances under product code JAC in the trailing twelve months.

FDA records show no clearances under product code JAC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260