# K981497: Steritec Disposable Biological Test Pack-EO Gas

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Oct 29, 1998 after 185 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 K895704 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 2.

## Indications for use
The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60% Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60 minutes.

Source page: https://510kreport.com/device/K981497
Methodology: https://510kreport.com/methodology