510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872319Substantially Equivalent

Ln 100 Breast Marker

Instrumentation Industries, Incorporated, Bethel Park PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872319 is the FDA 510(k) clearance record for LN 100 BREAST MARKER, a class I device, cleared for Instrumentation Industries, Inc. on under FDA product code FTY (Tape, Measuring, Rulers And Calipers). FDA records list 45 510(k) clearances for INSTRUMENTATION INDUSTRIES, INCORPORATED, from to . As of , FDA records show no recalls naming K872319.

Clearance record

Decision date
Received
(55 days to decision)
Product code
FTY Tape, Measuring, Rulers And Calipers
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Instrumentation Industries, Inc. 2990 Industrial Blvd., Bethel Park PA
Third party review
No

Clearances, product code FTY

Trailing 12 months

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

FDA records show no clearances under product code FTY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FTY, 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