# K150646: EOGas 4 Ethylene Oxide Gas Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 18, 2015 after 251 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: 1 generation back to K812867 (1981). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812867: Steri-Vac #400C Gas Sterilizer, 3M Company (1981) Summary page 6.
- (no number) Sterijet Ethylene Oxide Sterilization System: named in the summary without a submission number

## Most influential descendants
- K192978: EOGas 4 Ethylene Oxide Gas Sterilizer (2020), 0 descendants of its own
- K170432: Anprolene AN75 Ethylene Oxide Gas Sterilizer (2017), 0 descendants of its own

## Indications for use
The EOGas 4 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 3 hour cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices as well as for the sterilization of single-lumen flexible endoscopes. The 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 EO Amount: 17.6 g ± 5%; Temperature: 50°C ± 3°C; Relative Humidity: 35-70%; EO Exposure Time: 3 hours; Total Cycle Time: 3.5 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 EOGas 4 Ethylene Oxide Gas Sterilizer Metal — Maximum load: 24 lbs (11 kg). Device examples: Surgical instruments, delicate sharps, including those with hinges and mated surfaces. Required aeration: Metal instruments do not absorb EO; follow pouch or wrap manufacturer’s instructions (Example: Tyvek® pouches and Sterisheet® wrap require ≥ 6 hours at 50°C). Plastic — Maximum load: 7.0 lbs (3.2 kg). Device examples: Reusable power cords, trocars. Required aeration: 24 hours at 50°C; follow manufacturer’s instructions. Fabric — Maximum load: 6.1 lbs (2.8 kg). Device examples: Reusable cloth gowns, towels. Required aeration: Follow manufacturer’s instructions. Single-lumen Endoscope(s) — One (1) ≥ 2.0mm ID, ≤ 1100mm length; no additional devices. Device examples: Gastrovideoscopes, gastrointestinal videoscopes. Four (4) ≥ 1.2 mm ID, ≤ 700 mm length; no additional devices. Device examples: Bronchoscopes, bronchovideoscopes, cystoscopes, ureteroscopes, choledocoscopes. Required aeration: 12 hours at 50°C; follow manufacturer’s instructions. Reusable medical devices must be aerated following the instructions of the device manufacturer and the packaging material manufacturer, then released for use after sterilization based on successful inactivation of an EZTest®- Gas Biological Indicator in the Andersen EOGas 4 SteriTest process challenge device.

Source page: https://510kreport.com/device/K150646
Methodology: https://510kreport.com/methodology