Product code QKM— General Hospital
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- Classification name
- A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.”
Market context for product code QKM
FDA has cleared devices under product code QKM between 2020 and 2024, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2022
- 2020
Top applicants under product code QKM
Recent clearances under product code QKM
- K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- K212022 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K213262 — CELERITY HP Chemical Indicator
- K203284 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
- K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Data sourced from openFDA. This site is unofficial and independent of the FDA.