OPA 30 Solution
510(k) K140703
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140703 | Date19 Aug 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MED
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6885
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The OPA 30 Solution is a sterilant designed for high-level disinfection of heat-sensitive, semi-critical medical devices. According to regulatory classification, it falls under the category of sterilants for medical devices, ensuring microbial decontamination where sterilization is impractical or unsuitable.
This solution is intended for use in general hospital settings and is supplied as a liquid for reprocessing devices that cannot withstand traditional sterilization methods. It is classified as a Class II medical device under FDA regulations (880.6885) and has received FDA 510(k) clearance as substantially equivalent to a legally marketed predicate. The product is not described as single-use or reusable in the regulatory data, and no MRI safety or sterility specifications are provided.
Other devices from Ciden Technologies, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the OPA 30 Solution used for?
The OPA 30 Solution is designed for high-level disinfection of heat-sensitive, semi-critical medical devices. It is specifically intended for reprocessing devices where traditional sterilization methods—such as heat or steam—are impractical or unsuitable due to material limitations. This ensures microbial decontamination to a level appropriate for devices that come into contact with mucous membranes or non-intact skin.
How is the OPA 30 Solution supplied?
The OPA 30 Solution is supplied as a liquid formulation. It is intended for use in liquid-based disinfection processes within hospital settings, where it can be applied to devices that cannot withstand traditional sterilization techniques. The exact packaging details (e.g., bottle size, concentration) are not specified in the regulatory data, but it is classified as a liquid sterilant.
Is the OPA 30 Solution single-use or reusable?
The regulatory data does not explicitly state whether the OPA 30 Solution itself is single-use or reusable. However, as a sterilant/disinfectant, it is typically used in a closed-loop system where the solution is reused multiple times before disposal or reprocessing. The focus is on the devices being disinfected rather than the solution’s reuse status, which would depend on manufacturer guidelines and facility protocols.
What regulatory approval does the OPA 30 Solution hold?
The OPA 30 Solution has received FDA 510(k) clearance under the classification of sterilants for medical devices (product code MED, regulation number 880.6885). It is deemed substantially equivalent to a legally marketed predicate device, meaning it meets the FDA’s requirements for safety and effectiveness as determined through the 510(k) review process. This clearance applies to its use as a high-level disinfectant in general hospital settings.
Are there specific storage requirements for the OPA 30 Solution?
The regulatory data does not provide explicit storage instructions for the OPA 30 Solution. However, as with most chemical sterilants/disinfectants, it is generally recommended to store the solution in a cool, dry place, away from direct sunlight and incompatible substances. Proper labeling and handling per manufacturer guidelines are critical to maintaining efficacy and safety. Always refer to the product’s accompanying documentation for detailed storage recommendations.