ATI Ethylene Oxide Sterilization Indicator
by Pymah Corp. 510(k)
Active
510(k) K952995
Overview
This device is a Physical/Chemical Sterilization Process Indicator, designed to verify the effectiveness of ethylene oxide sterilization cycles. It provides visual confirmation that the sterilization process has been completed according to specified parameters, ensuring the integrity of sterilized medical devices and instruments.
The indicator is supplied as a single-use, non-sterile component and is intended for use in ethylene oxide sterilization systems within hospital or clinical settings. It is classified as a Class II device under FDA regulations and requires compliance with sterilization validation protocols. No MRI safety information is provided, and storage conditions are not specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952995 | Date22 Feb 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JOJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pymah Corp.
Questions
What is the primary purpose of the ATI Ethylene Oxide Sterilization Indicator, and how does it function in a clinical setting?
The ATI Ethylene Oxide Sterilization Indicator is designed to visually confirm whether an ethylene oxide sterilization cycle has been completed effectively. It serves as a physical/chemical process indicator, ensuring that medical devices or instruments exposed to the sterilization process meet the required parameters. In clinical settings, it provides reassurance that sterilized items are safe for use, helping to maintain the integrity of sterilization protocols in hospitals or other healthcare environments.
Is the ATI Ethylene Oxide Sterilization Indicator reusable, or is it intended for single-use only?
The ATI Ethylene Oxide Sterilization Indicator is explicitly supplied as a single-use component. This means each indicator is intended for one sterilization cycle only and should not be reused, as its purpose is to provide a one-time visual confirmation of the sterilization process.
How should the ATI Ethylene Oxide Sterilization Indicator be stored, and are there any specific handling instructions?
The provided data does not specify storage conditions for the ATI Ethylene Oxide Sterilization Indicator. However, since it is a non-sterile single-use indicator, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Always follow manufacturer guidelines (if available) or facility protocols for optimal shelf life and usability.
What regulatory pathway was followed for the FDA clearance of this device, and what class does it fall under?
The ATI Ethylene Oxide Sterilization Indicator was cleared through the FDA’s 510(k) Traditional pathway under the Substantially Equivalent (SESE) determination. It is classified as a Class II device, which means it carries a moderate regulatory risk and requires compliance with specific controls to ensure its safety and effectiveness in verifying ethylene oxide sterilization cycles.
Can this indicator be used in any ethylene oxide sterilization system, or are there specific system requirements?
The indicator is intended for use in ethylene oxide sterilization systems within hospital or clinical settings, but the data does not specify compatibility with all systems. It is designed to work within standard ethylene oxide sterilization protocols, so it should be used according to the manufacturer’s instructions and facility-specific sterilization validation protocols. Always ensure the sterilizer’s specifications align with the indicator’s intended use.