# K921909: Sterrad BI Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Oct 1, 1993 after 526 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.
2 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991675: Modification of: Sterrad BI Test Pack (1999), 1 descendant of its own
- K993775: Sterrad BI Test Pack (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K921909
Methodology: https://510kreport.com/methodology