# K040901: Steritec Emu-Graph, Model NO. CI 131/US

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products, Inc.
- Decided: Sep 9, 2004 after 155 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-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132 ° C (270 F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to green color,

Source page: https://510kreport.com/device/K040901
Methodology: https://510kreport.com/methodology