# K102894: Classix Chemical Sterilization Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Mfg. Co., Inc.
- Decided: May 25, 2011 after 237 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
Longest line of descent: 3 generations back to K801109 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895910: Steamline, Propper Mfg. Co., Inc. (1990) Summary page 2.
- K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator, STERIS Corporation (2007) Summary page 2.
- K070461: Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4, STERIS Corporation (2007) Summary page 2.

## Indications for use
The Emu-Chex Sterilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Emu-Chex Sterilization Indicator comes in three varieties: for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pre-vacuum steam sterilization processes operating at 132°C for 4 minutes and 135°C for 3 minutes, The Emu-Chex Sterilization Indicators can be placed together with items to be steam sterilized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Emu-Chex Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.

Source page: https://510kreport.com/device/K102894
Methodology: https://510kreport.com/methodology