# K952244: Cross-Checks EO Gas Sterilization Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Aug 5, 1996 after 451 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Surgicot 2% EO Gas Indicator: named in the summary without a submission number

## Indications for use
SteriTec CROSS-CHECKS EO gas process indicator monitoring strips are a yellow to brown chemical indicator strip that changes color during Ethylene Oxide (EO) processing. They indicate that the item has been processed in Ethylene Oxide.

Source page: https://510kreport.com/device/K952244
Methodology: https://510kreport.com/methodology