# K801109: Proof (Biological/Chemical Indicator)

- Pathway: 510(k) (Traditional)
- Applicant: Amsco Co.
- Decided: May 30, 1980 after 18 days
- Product code: JOJ (Indicator, Physical/Chemical 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.
19 later devices descend from it; 2 cite it directly.
0 of 20 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
- K963841: Eztest (1997), 12 descendants of its own
- K930683: Eztest-Gas (1997), 5 descendants of its own
- K151585: Andersen EOGas 4 SteriTest (2015), 3 descendants of its own
- K070595: Sporview Steam Self-Contained Biological Indicator (2007), 3 descendants of its own
- K111515: Spsmedical Sporview Steam BI (2012), 2 descendants of its own

Source page: https://510kreport.com/device/K801109
Methodology: https://510kreport.com/methodology