# K083665: Verify Scbi 275F 3-10

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Sep 1, 2009 after 265 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801109 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051056: Verify Self-Contained Biological Indicator, Albert Browne, Ltd. (2005) Summary page 2.
- K855101: Assert TM Biological/Chemical Indicator, Surgicot, Inc. (1986) Summary page 2.
- K963841: Eztest, Sgm Biotech, Inc. (1997) Summary page 2.

## Recalls of this device
- Aug 31, 2026 · Class II · Z-0073-2027: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the 
- Aug 31, 2026 · Class II · Z-0072-2027: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the 
- Dec 12, 2022 · Class II · Z-0778-2023: Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intend
- Dec 12, 2022 · Class II · Z-0779-2023: Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intend
- Dec 12, 2022 · Class II · Z-0780-2023: Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intend
- Dec 12, 2022 · Class II · Z-0781-2023: Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intend
- Sep 10, 2013 · Class II · Z-0605-2014: STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Cont

## Indications for use
The Verify® SCBI 275F 3-10 is a self-contained biological indicator that may be used for installation testing and routine monitoring of steam sterilizers. The Verify® SCBI 275F 3-10 provides independent confirmation that sterilization conditions were achieved during the following cycles: 275°F (135 0C) Gravity Flash 3 minutes 275°F (135 0C) Prevacuum 3 minutes 275°F (135 0C) Gravity 10 minute 275°F (135°C) Gravity Flash 10 minutes

Source page: https://510kreport.com/device/K083665
Methodology: https://510kreport.com/methodology