# K170439: AN87 Dosimeter

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 1, 2017 after 261 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 K150645 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150645: AN1087 Dosimeter, Andersen Sterilizers, Inc. (2015) Summary page 5.

## Indications for use
AN87 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in 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/K170439
Methodology: https://510kreport.com/methodology