Cleared Traditional

CELERITY HP Chemical Indicator

K213262 · STERIS Corporation · General Hospital

Jan 2022

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K213262 is an FDA 510(k) clearance for the CELERITY HP Chemical Indicator, a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II — Special Controls, product code QKM), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 7, 2022, 99 days after receiving the submission on September 30, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K213262 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2021
Decision Date	January 07, 2022
Days to Decision	99 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.