Verify 275F Gravity Indicators
510(k) K083643
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083643 | Date7 Aug 2009 | 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- Withdrawn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
- JOJ
- Device class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Verify 275F Gravity Indicators are a type of indicator used in physical or chemical sterilization processes. These devices visually confirm the completion of a sterilization cycle by responding to gravitational forces, ensuring proper exposure to sterilization conditions such as steam, ethylene oxide, or other sterilants. They are designed to provide a reliable, colorimetric indication of successful sterilization when oriented correctly during the process.
These indicators are supplied as single-use items and are intended for use in healthcare settings, including general hospitals. They are non-sterile before use and must be activated by exposure to the sterilization process. The indicators are classified as Class II medical devices under FDA regulations and are regulated under product code JOJ for physical/chemical sterilization indicators. They are packaged in bulk quantities, such as 100 indicators per box, and require proper storage to maintain integrity until use.
Other devices from Steris Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the purpose of the Verify 275F Gravity Indicators?
The Verify 275F Gravity Indicators are designed to visually confirm the completion of a sterilization cycle by responding to gravitational forces. This ensures proper exposure to sterilization conditions such as steam, ethylene oxide, or other sterilants, providing a reliable way to verify successful sterilization when the indicator is oriented correctly during the process.
Are these indicators single-use or reusable?
These indicators are intended for single-use only. They are non-sterile before activation and must be exposed to the sterilization process to become activated, making reuse unsafe and ineffective.
How are the Verify 275F Gravity Indicators supplied?
The indicators are packaged in bulk quantities, with each box containing 100 indicators. Proper storage is required to maintain their integrity until use, ensuring they function correctly during the sterilization process.
Do these indicators require any special handling before use?
Yes, the Verify 275F Gravity Indicators are non-sterile before use and must be activated by exposure to the sterilization process. They should be stored in their original packaging until ready for use to preserve their functionality.
What types of sterilization processes can these indicators monitor?
These indicators are suitable for monitoring physical or chemical sterilization processes, including steam, ethylene oxide, and other sterilants commonly used in healthcare settings like general hospitals.