# K170432: Anprolene AN75 Ethylene Oxide Gas Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Oct 31, 2017 after 260 days
- Product code: FLF (Sterilizer, Ethylene-Oxide Gas)
- Device class: 2
- Regulation: 21 CFR 880.6860
- 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 K812867 (1981). 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)
- K150646: EOGas 4 Ethylene Oxide Gas Sterilizer, Andersen Sterilizers, Inc. (2015) Summary page 5.
- (no number) B-2270/AN70 Anprolene Sterilizer: named in the summary without a submission number

## Indications for use
The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The 12 hour cycle at 20-29ºC in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces. The 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 EO Amount: 17.6 g ± 5%; Temperature: 20-29°C (68-84ºF); Relative Humidity: 35-70%; EO Exposure Time: 12 hours; Total Cycle Time: 14 hours Maximum loads of specific materials and devices that have been validated are listed in Table 2. All validated maximum loads were processed without additional devices in the sterilizer. Table 2. Load and material types validated in the Anprolene AN75 Ethylene Oxide Gas Sterilizer Device Type: Metal. Maximum Load: 24 lbs (11 kg). Device Examples: Delicate sharps and surgical instruments, including those with hinges and mated surfaces. Required Aeration: Metal instruments do not absorb EO; Follow pouch or wrap manufacturer’s instructions (Example: Sterisheet® wraps require ≥ 6 hours at 20-29°C). Device Type: Plastic. Maximum Load: 3.5 lbs (1.6 kg). Device Examples: Reusable power cords, trocars. Required Aeration: Follow manufacturer’s instructions; 24 hours at 20-29°C. Device Type: Fabric. Maximum Load: 3.0 lbs (1.4 kg). Device Examples: Reusable cloth gowns, towels. Required Aeration: Follow manufacturer’s instructions; 24 hours at 20-29°C. Reusable medical devices must be aerated following the instructions of device manufacturers and packaging material manufacturers, then released for use after sterilization based on successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device.

Source page: https://510kreport.com/device/K170432
Methodology: https://510kreport.com/methodology