# K895704: Ati Disp. Biological Test Pack for Ethylene Oxide

- Pathway: 510(k) (Traditional)
- Applicant: Pymah Corp., Ati Div.
- Decided: Mar 8, 1990 after 167 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K930683: Eztest-Gas (1997), 5 descendants of its own
- K151585: Andersen EOGas 4 SteriTest (2015), 3 descendants of its own
- K202879: EOGas 4 Endo-SteriTest RRBI (2021), 0 descendants of its own
- K192980: EOGas 4 Endo-SteriTest (2020), 0 descendants of its own
- K170427: Anprolene SteriTest (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K895704
Methodology: https://510kreport.com/methodology