# K150644: AN85/AN86 EO Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 18, 2015 after 251 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: 1 generation back to K991418 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991418: Browne Mvi Ethylene Oxide Indicator, Albert Browne, Ltd. (1999) Summary page 5.

## Most influential descendants
- K170426: AN85/AN86 EO Indicators (2017), 0 descendants of its own

## Indications for use
The AN85/AN86 EO Indicators are single-use Class 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 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer Ethylene Oxide Temperature Relative Humidity Ethylene Oxide Exposure Time Total Cycle Time 17.6 g ± 5% 50°C ± 3°C 35-90% 3 hours 3.5 hours

Source page: https://510kreport.com/device/K150644
Methodology: https://510kreport.com/methodology