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

A Chemical Vapor Sterilization Multivariable Chemical Indicator

21 CFR 880.2800 / General Hospital
FDA source (opens on fda.gov)

QKM is the FDA product code for A Chemical Vapor Sterilization Multivariable Chemical Indicator, a class II device type, regulated under 21 CFR 880.2800. FDA's definition for this code reads: "A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QKM
Device name
A Chemical Vapor Sterilization Multivariable Chemical Indicator
FDA definition
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QKM

By decision year
5 clearances under product code QKM with a decision year between 2020 and 2024, 2020 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QKM by decision year
YearClearances
20202
20222
20241

Applicants with the most clearances

Product code QKM
Applicants holding the most 510(k) clearances under product code QKM
ApplicantClearances
3M Company2
3M Healthcare1
STERIS Corporation1
Terragene LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code