Biosign STEAM-24 Biological Indicator
510(k) K032723
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032723 | Date1 Oct 2003 | 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- Withdrawn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
- FRC
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Biosign Steam-24 Biological Indicator is a self-contained biological indicator used to monitor steam sterilization processes. It is designed for biological testing of 121°C and 134°C gravity, pre-vacuum, and flash steam sterilization cycles.
This device provides results after 24 hours of incubation. It has received FDA 510(k) clearance for use in general hospital settings.
Other devices from Getinge USA, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Biosign Steam-24 Biological Indicator used for?
This device is a self-contained biological indicator designed to monitor steam sterilization processes. It is specifically used for the biological testing of gravity, pre-vacuum, and flash steam sterilization cycles at temperatures of 121°C and 134°C.
How long does it take to get results from this indicator?
The Biosign Steam-24 provides results after 24 hours of incubation. This timeframe allows for the necessary biological assessment of the sterilization cycle effectiveness.
Is this device cleared for use in clinical settings?
Yes, the Biosign Steam-24 Biological Indicator has received FDA 510(k) clearance for use in general hospital settings to verify the performance of steam sterilization equipment.