# K170426: AN85/AN86 EO Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Oct 30, 2017 after 259 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: 2 generations back to K991418 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150644: AN85/AN86 EO Indicators, Andersen Sterilizers, Inc. (2015) Summary page 5.

## Indications for use
AN85/AN86 EO Indicators are single-use Type 1 process indicators used to distinguish between processed and unprocessed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer Ethylene Oxide Temperature Relative Humidity Ethylene Oxide Exposure Time Total Cycle Time 17.6 g ± 5% 20-29°C 35-90% 12 hours 14 hours

Source page: https://510kreport.com/device/K170426
Methodology: https://510kreport.com/methodology