# K083650: Emu-Graph 4 Emulator, Model CI 144

- Pathway: 510(k) (Special)
- Applicant: Steritec Products, Inc.
- Decided: Mar 5, 2009 after 86 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
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.

## Recalls of this device
- Jul 15, 2009 · Not classified · Z-1531-2010: This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data o

## Indications for use
SteriTec Emu-Graph 4 is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 1320C (2700 F) or 1350 C (2750 F). When exposed to steam sterilization conditions the indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met.

Source page: https://510kreport.com/device/K083650
Methodology: https://510kreport.com/methodology