FDA Product Code QKM: A Chemical Vapor Sterilization Multivariable Chemical Indicator
A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process.
Leading manufacturers include 3M Company, STERIS Corporation and Terragene S.A..
5
Total
5
Cleared
162d
Avg days
2020
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared A Chemical Vapor Sterilization Multivariable Chemical Indicator Devices (Product Code QKM)
5 devices
Cleared
Apr 05, 2024
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Terragene S.A.
General Hospital
266d
Cleared
Apr 20, 2022
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
3M Company
General Hospital
295d
Cleared
Jan 07, 2022
CELERITY HP Chemical Indicator
STERIS Corporation
General Hospital
99d
Cleared
Dec 07, 2020
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
3M Company
General Hospital
28d
About Product Code QKM - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QKM since 2020, with 5 receiving FDA clearance (average review time: 162 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QKM devices are reviewed by the General Hospital panel. Browse all General Hospital devices →