Castle 3241 Gas Aerator

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K813201 ↗

FDA Product Code

FLI

Device Class

Class II

Regulation

21 CFR Part 880.6100

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the Castle #3241 Gas Aerator used for?

  The Castle #3241 Gas Aerator is designed to remove and disperse residual ethylene oxide gas from sterilization chambers after a sterilization cycle. This ensures safe ventilation within ethylene oxide sterilization systems, minimizing exposure risks in medical environments like general hospitals.

• Is the Castle #3241 Gas Aerator reusable or single-use?

  The Castle #3241 Gas Aerator is supplied as a reusable component. It must be properly installed within an ethylene oxide sterilization cabinet and maintained according to manufacturer guidelines to ensure continued functionality and safety.

• Where is this device intended for use?

  This device is intended for use in general hospital settings, specifically within ethylene oxide sterilization systems. Its design ensures safe gas dispersion in environments where medical instruments and supplies are sterilized using ethylene oxide.

• How should the Castle #3241 Gas Aerator be stored?

  Storage and maintenance of the Castle #3241 Gas Aerator should follow the manufacturer’s guidelines to preserve functionality and compliance with regulatory standards. Proper handling ensures the device operates effectively in reducing residual ethylene oxide gas exposure.

• What regulatory clearance does the Castle #3241 Gas Aerator hold?

  The Castle #3241 Gas Aerator holds an FDA 510(k) clearance under the Traditional 510(k) Review Process, with clearance number K813201. It was determined to be substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device.