# K150645: AN1087 Dosimeter

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 19, 2015 after 252 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) AN87 Dosimeter: named in the summary without a submission number

## Most influential descendants
- K200334: AN1036 Dosimeter (2020), 0 descendants of its own
- K170439: AN87 Dosimeter (2017), 0 descendants of its own

## Indications for use
AN1087 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 3 hour sterilization cycle at 50°C in the Andersen Sterilizers EOGas 4 Ethylene Oxide Gas Sterilizer. 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/K150645
Methodology: https://510kreport.com/methodology