# K972300: Cross-Checks P

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Mar 25, 1998 after 279 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921910 (1993). 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)
- K921910: Sterrad Chemical Indicator, Johnson & Johnson Medical, Inc. (1993) Summary page 2.

## Recalls of this device
- Jul 15, 2009 · Not classified · Z-1532-2010: This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their products. There is insufficient data on file to support the sh

## Indications for use
Cross-Checks P chemical process indicator strips are designed to be used in the Sterrad sterilizer. Cross-Checks P Process Indicator Strips will exhibit a blue to red color change when exposed to hydrogen peroxide during the diffusion phase of the Sterrad cycle. When used as directed, the Cross-Checks P strips give visible confirmation that the item has been exposed to hydrogen peroxide during the Sterrad cycle.

Source page: https://510kreport.com/device/K972300
Methodology: https://510kreport.com/methodology