# K993775: Sterrad BI Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Jun 1, 2000 after 206 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: 2 generations back to K921909 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921909: Sterrad BI Test Pack, Johnson & Johnson Medical, Inc. (1993) Summary page 1.
- K991675: Modification of: Sterrad BI Test Pack, Advanced Sterilization Products (1999) Summary page 1.

## Indications for use
The STERRAD®BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

Source page: https://510kreport.com/device/K993775
Methodology: https://510kreport.com/methodology