# K955426: Steritec Cross-Checks

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Mar 12, 1996 after 105 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) ATI Division of PyMah Corporation Sterilometer Steam Strip® chemical indicator strip for steam: named in the summary without a submission number

## Indications for use
SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process. They are designed to be placed in each pack or package to be steam or chemical vapor sterilized, to indicate an item has been exposed to a steam Or vapor process.

Source page: https://510kreport.com/device/K955426
Methodology: https://510kreport.com/methodology