Trophon Chemical Indicator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103126 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Trophon Chemical Indicator is a chemical indicator designed for use in physical or chemical sterilization processes. It visually confirms the completion of sterilization cycles by changing colour, ensuring the integrity of the sterilisation process for medical devices and equipment.
This indicator is supplied as a single-use device and is intended for use in hospital settings, particularly within general hospital environments. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorisation. The indicator is non-sterile and must be used in accordance with the manufacturer’s instructions to validate sterilisation cycles for various medical devices.
Frequently asked questions
What is the primary purpose of the Trophon Chemical Indicator in a hospital setting?
The Trophon Chemical Indicator is designed to visually confirm the completion of physical or chemical sterilization processes. By changing color, it ensures the sterilization cycle has been properly executed, helping validate the integrity of sterilized medical devices and equipment in hospital environments.
Is the Trophon Chemical Indicator reusable or intended for single-use?
The Trophon Chemical Indicator is explicitly supplied as a single-use device. Each indicator is meant to be used once per sterilization cycle, after which it should be discarded to maintain accuracy and reliability.
How should the Trophon Chemical Indicator be stored before use?
The device is non-sterile, so it does not require sterile storage conditions. However, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use, following the manufacturer’s instructions.
Can this indicator be used across multiple types of sterilization processes?
Yes, the Trophon Chemical Indicator is validated for use in physical or chemical sterilization processes, making it suitable for a wide range of sterilization methods as referenced in its regulatory submissions (e.g., FEI numbers). However, it must be used strictly according to the manufacturer’s guidelines for each specific process.
What regulatory pathways has the Trophon Chemical Indicator followed for approval?
The Trophon Chemical Indicator has received FDA 510(k) clearance and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. It is classified as a Class II medical device under FDA regulations, indicating a moderate risk level requiring pre-market review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K103126 | Class II | Active |
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Manufacturer
- Manufacturer
- Nanosonics Limited
Sources (2)
- FDA 510(k) K103126 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026