Ethylene Oxide Sterilization Indicator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K772358 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)
This device is a Physical/Chemical Sterilization Process Indicator, designed to verify the effectiveness of ethylene oxide sterilization cycles. It provides a visible confirmation of gas penetration into sterilized materials, ensuring proper exposure during the process. The indicator also functions as a biological control, integrating spore testing to validate the sterilization procedure.
The Ethylene Oxide Sterilization Indicator is supplied as a single-use indicator system, intended for use in healthcare settings where ethylene oxide sterilization is applied. It is not MRI-safe and requires proper handling and storage as a non-sterile item prior to use. Authorized under FDA 510(k) clearance (K772358), this device is classified as a Class II medical device under regulation number 880.2800. No additional regulatory markings or sterility claims are provided.
Frequently asked questions
What is the Ethylene Oxide Sterilization Indicator used for?
This indicator is designed to confirm the effectiveness of ethylene oxide sterilization processes. It visually confirms gas penetration into sterilized materials and integrates spore testing to validate the entire sterilization cycle. This ensures that medical devices and supplies are properly exposed to ethylene oxide, reducing the risk of contamination.
How is the Ethylene Oxide Sterilization Indicator supplied and intended for use?
The indicator is supplied as a single-use system, specifically for healthcare environments where ethylene oxide sterilization is applied. It is not intended for reuse and must be handled as a non-sterile item before use. This ensures each sterilization cycle is independently verified without carryover risks.
Is the Ethylene Oxide Sterilization Indicator sterile before use?
No, the indicator is not sterile prior to use. It is supplied in a non-sterile state and is intended to be used as part of the sterilization process itself. Sterility is confirmed only after the ethylene oxide cycle completes, as indicated by the device’s response.
Can this indicator be used in MRI environments?
No, the Ethylene Oxide Sterilization Indicator is explicitly noted as not MRI-safe. This means it should not be used or stored in areas where MRI procedures are conducted, as it may interfere with imaging or pose safety risks.
What regulatory approval does this device hold?
The Ethylene Oxide Sterilization Indicator is authorized under FDA 510(k) clearance with the designation K772358. It is classified as a Class II medical device under regulation number 880.2800, indicating it has undergone substantial equivalence review by the FDA for safety and effectiveness.
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. Sources consulted: ETHYLENE OXIDE STERILI. INDICATOR (K772358) — FDA 510(k) | Innolitics, ETHYLENE OXIDE STERILI. INDICATOR 510(k) K772358 - FDA.report, Biological-Chemical Indicator for Ethylene Oxide Sterilization, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K772358 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Sciences, Inc.
Sources (1)
- FDA 510(k) K772358 24 fields · synced Oct 1, 2026