Sterilization Indicator/Seal Protector JOJ
510(k) K811408
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811408 | Date12 Jun 1981 | 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- Withdrawn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
- Full name
- Sterilization Indicator/Seal Protector
- 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
Overview
AI-generated summary, 19 Sep 2026
This device is a sterilization indicator/seal protector, designed to monitor the integrity of sterilization packaging and ensure proper sealing. It visually confirms whether a package has been exposed to a sterilization process, helping prevent contamination by validating that the seal remains intact after sterilization.
The Sterilization Indicator/Seal Protector JOJ is intended for use in general hospital settings and is classified as a Class II device under FDA regulations. It is supplied as a single-use item and is not intended for reuse. No MRI safety or specific size details are provided in the regulatory data, though it is associated with traditional sterilization processes. Authorized under FDA 510(k) clearance K811408, this device adheres to Regulation Number 880.2800 and was determined to be substantially equivalent to predicate devices.
Other devices from Beacon Converters, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Sterilization Indicator/Seal Protector from Beacon Converters, Inc. in a hospital setting?
The Sterilization Indicator/Seal Protector is designed to monitor the integrity of sterilization packaging and ensure proper sealing. It visually confirms whether a package has been exposed to a sterilization process, helping prevent contamination by validating that the seal remains intact after sterilization. This is critical for maintaining sterile environments in general hospital settings.
Is the Sterilization Indicator/Seal Protector intended for reuse, or is it meant to be used only once?
The Sterilization Indicator/Seal Protector is explicitly supplied as a single-use item and is not intended for reuse. This ensures reliability and prevents potential cross-contamination between sterilization cycles.
How is this device regulated, and what does its FDA clearance indicate?
The Sterilization Indicator/Seal Protector is classified as a Class II device under FDA regulations and was granted 510(k) clearance (K811408). This clearance indicates that the device was determined to be substantially equivalent to a predicate device already on the market, meaning it meets the same performance standards and regulatory requirements.
Are there specific storage requirements mentioned for this device?
The provided regulatory data does not specify detailed storage requirements such as temperature or environmental conditions. However, since it is a single-use sterilization indicator, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use.
Does this device have any compatibility restrictions, such as MRI safety concerns?
The regulatory data does not mention any MRI safety considerations for the Sterilization Indicator/Seal Protector. However, since it is designed for traditional sterilization processes (not MRI-related), it is not intended for use in MRI environments. Always verify compatibility with your facility’s specific sterilization protocols.