510(k) · Cleared
ClearedTerragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terragene S.A. · QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Cleared on Apr 5, 2024 after a 266-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 5, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- QKM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QKM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QKM device
- #1 K212022 3M Attest Vaporized Hydrogen Peroxide…score 8.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QKM devicesQKM A Chemical Vapor Sterilization Multivariable Chemical Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QKM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QKM
Too few QKM 510(k)s in any year since 2007 to give a median.
Recalls per year · QKM
No recall names QKM since 2007.
Adverse event reports per year · QKM
No MAUDE report names QKM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Terragene® Chemdye® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® NX Sterilization System (Standard and Advanced cycles). • Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles). • Sterrad® 100NX Sterilization System…
Read the full statement (387 words)
Terragene® Chemdye® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
• Sterrad® 100S Sterilization System.
• Sterrad® NX Sterilization System (Standard and Advanced cycles).
• Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• Sterrad® l00NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible cycles).
The chemical indicator changes from purple to green to indicate that the conditions of the cycle have been met.
Terragene® Chemdye® Chemical Process Indicator (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
• Sterrad® 100S Sterilization System.
• Sterrad® NX Sterilization System (Standard and Advanced cycles).
• Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• Sterrad® l00NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible cycles).
• Sterizone® VP4 Sterilizer (Cycle 1).
The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene® Cintape® Chemical Process Indicator Tape (CT40) is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
• Sterrad® 100S Sterilization System.
• Sterrad® NX Sterilization System (Standard and Advance cycles).
• Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• Sterrad® l00NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible cycles).
• Sterizone® VP4 Sterilizer (Cycle 1).
The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K232103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232103: Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232103
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026