# K051056: Verify Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Oct 20, 2005 after 177 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K855101 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K855101: Assert TM Biological/Chemical Indicator, Surgicot, Inc. (1986) Summary page 1.

## Most influential descendants
- K083665: Verify Scbi 275F 3-10 (2009), 0 descendants of its own

## Indications for use
The Verify® Self-Contained Biological Indicator may be used for installation testing and routine monitoring of the following steam sterilization cycle: 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle for packaged items

Source page: https://510kreport.com/device/K051056
Methodology: https://510kreport.com/methodology