Cleared Traditional

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

K193110 · 3M Healthcare · General Hospital

Mar 2020

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K193110 is an FDA 510(k) clearance for the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II — Special Controls, product code QKM), submitted by 3M Healthcare (Saint Paul, US). The FDA issued a Cleared decision on March 13, 2020, 122 days after receiving the submission on November 12, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K193110 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2019
Decision Date	March 13, 2020
Days to Decision	122 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.