# K012732: Integraph Flash, Model CI 110

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products, Inc.
- Decided: Mar 4, 2002 after 200 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SteriTec Integraph Flash is a steam sterilization integrator for use in either a pre-vacuum steam sterilization process of 3 minutes or longer at 132° C (270° F), or in gravity flash steam sterilization process for a 3 Minute cycle or 10 Minute cycle at 132° C (270° F). When exposed to steam sterilization conditions the Integraph Flash strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to a green color. The stated value in a laboratory test sterilizer for the 3-Minute indicator spot is 5 minutes at 132° C, and for the 10-Minute indicator spot is 11.5 minutes at 132° C.

Source page: https://510kreport.com/device/K012732
Methodology: https://510kreport.com/methodology