# K072408: Emu-Graph Emulator, Model CI 131

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Apr 30, 2008 after 247 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 Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions both the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature 4 MIN Indicator 132°C (270°F) 4 minutes 135°C (275°F) 3 minutes

Source page: https://510kreport.com/device/K072408
Methodology: https://510kreport.com/methodology