# K951113: Cross-Checks

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Aug 19, 1996 after 528 days
- Product code: LRT (Indicator, Sterilization)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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

## Most influential descendants
- K143117: Wire Sterilization Package with Indicators (2015), 0 descendants of its own
- K132291: Namsa Chemical Process (2014), 0 descendants of its own

## Indications for use
SteriTec CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132°C to 133°C (270°F to 276°F). When used as directed, the SteriTec Cross-Checks indicator strips give visible indication that sterilizing conditions were met. During steam sterilization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.

Source page: https://510kreport.com/device/K951113
Methodology: https://510kreport.com/methodology