# K991618: BI-O.K. Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Propper Mfg. Co., Inc.
- Decided: Jan 24, 2001 after 624 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Propper BI-O.K. steam biological indicator is indicated for use in testing both gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

Source page: https://510kreport.com/device/K991618
Methodology: https://510kreport.com/methodology