510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232103Substantially Equivalent

Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

Terragene LLC, Alvear, AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K232103 is the FDA 510(k) clearance record for Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40), a class II device, cleared for Terragene S.A. on under FDA product code QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator). FDA's definition for product code QKM reads: "A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process". FDA records list 9 510(k) clearances for Terragene S.A., from to . As of , FDA records show no recalls naming K232103.

Clearance record

Decision date
Received
(266 days to decision)
Product code
QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Terragene S.A. Ruta Nacional # 9, Km 280, Parque Industrial Micropi, Alvear, AR
510(k) summary
Statement
Third party review
No

Clearances, product code QKM

Trailing 12 months

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

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