# K930683: Eztest-Gas

- Pathway: 510(k) (Traditional)
- Applicant: Sgm Biomedical, Inc.
- Decided: Mar 4, 1997 after 1,483 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: 1 generation back to K801109 (1980). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895704: Ati Disp. Biological Test Pack for Ethylene Oxide, Pymah Corp., Ati Div. (1990) Summary page 3.
- K801109: Proof (Biological/Chemical Indicator), Amsco Co. (1980) Summary page 3.
- K902344: Ati Disposable Biological Test Pack for Steam Ster, Ati (1990) Summary page 6.
- (no number) Attest®: named in the summary without a submission number

## Most influential descendants
- 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
- K041784: Raven Protest - EO (2004), 0 descendants of its own

## Indications for use
EZTest® - Gas self contained biological indicators are for monitoring the efficacy of ethylene oxide gas sterilization processors. Performance characteristics are established in accordance with USP XXIil for the 600mg/l process.

Source page: https://510kreport.com/device/K930683
Methodology: https://510kreport.com/methodology