Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
FDA 510(k) K232103 · Terragene S.A.
510(k) numberK232103
Submission
- Device name
- Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- Applicant
- Terragene S.A.
Alvear, AR - Received
- July 14, 2023
- Decision date
- April 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- QKM – A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Other 510(k)s with product code QKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM · Traditional | 3M Company | 04/20/2022SE |
| K213262 | CELERITY HP Chemical IndicatorQKM · Traditional | STERIS Corporation | 01/07/2022SE |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical IndicatorQKM · Special | 3M Company | 12/07/2020SE |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM · Traditional | 3M Healthcare | 03/13/2020SE |
More from 3M Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | 12/12/2024SE |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova®…FRC · Traditional | 09/18/2024SE |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper…FRC · Traditional | 02/28/2023SE |
| K200272 | Terragene ChemdyeJOJ · Traditional | 06/30/2020SE |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene…FRC · Traditional | 09/13/2019SE |
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD…FRC · Traditional | 11/02/2017SE |
Questions and answers
When was Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) cleared by the FDA?
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K232103) received a 510(k) decision of Substantially Equivalent on April 5, 2024, 266 days after the submission was received.
What is the product code of K232103?
The FDA product code is QKM – A Chemical Vapor Sterilization Multivariable Chemical Indicator, a Class II (moderate risk) device regulated under 21 CFR 880.2800.