# K855101: Assert TM Biological/Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Surgicot, Inc.
- Decided: Jul 17, 1986 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K051056: Verify Self-Contained Biological Indicator (2005), 1 descendant of its own
- K091950: Smart-Well Eztest Incubator (2010), 0 descendants of its own
- K083665: Verify Scbi 275F 3-10 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K855101
Methodology: https://510kreport.com/methodology