# K200334: AN1036 Dosimeter

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 12, 2020 after 275 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 4.

## Indications for use
AN1036 Dosimeter is a single-use color change chemical indicator. It is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in a 3-hour or 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycles are summarized in Table 1. Table 1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer Ethylene Oxide Temperature Relative Humidity EO Exposure Time Total Cycle Time 17.6 g £ 5% 50°C = 3°C 35-70% 3 hours 3.5 hours 6 hours 7 hours

Source page: https://510kreport.com/device/K200334
Methodology: https://510kreport.com/methodology