Cleared Traditional

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

K232103 · Terragene S.A. · General Hospital

Apr 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K232103 is an FDA 510(k) clearance for the Terragene? Chemdye? Multivariable Chemical Indicator (CD40), Terragene? Chemdye? Chemical Process Indicator (CD42), Terragene? Cintape? Chemical Process Indicator Tape (CT40), a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II — Special Controls, product code QKM), submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on April 5, 2024, 266 days after receiving the submission on July 14, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K232103 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2023
Decision Date	April 05, 2024
Days to Decision	266 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	QKM — A Chemical Vapor Sterilization Multivariable Chemical Indicator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2800
Definition	A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process.