# K100891: Dana Emulating Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Dana Products, Inc.
- Decided: Jan 13, 2011 after 288 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
Dana Emulating Indicator is for use in 4 minute 270'F (I132 0 C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature: 270'F (I132') Time: 4 Minutes

Source page: https://510kreport.com/device/K100891
Methodology: https://510kreport.com/methodology