510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K882519Substantially Equivalent

X-Ray Marker

Karlin Technology, Inc., Marina Del Rey CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882519 is the FDA 510(k) clearance record for X-RAY MARKER, a class I device, cleared for Karlin Technology, Inc. on under FDA product code JAC (System, X-Ray, Film Marking, Radiographic). FDA records list 17 510(k) clearances for Karlin Technology, Inc., from to . As of , FDA records show no recalls naming K882519.

Clearance record

Decision date
Received
(53 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
Karlin Technology, Inc. 330 Washington St., Marina Del Rey 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