Extrapure Reverse Osmosis Water Unit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K822385 ↗

FDA Product Code

FIP

Device Class

Class II

Regulation

21 CFR Part 876.5665

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Extracorporeal Medical Specialities, Inc. →

• What types of clinical or research settings is the Extrapure Reverse Osmosis Water Unit intended for use in?

  The Extrapure Reverse Osmosis Water Unit is designed for clinical and research environments where high-purity water is required. Its reverse osmosis technology ensures contaminants, ions, and microorganisms are removed, making it suitable for sensitive procedures in medical and laboratory settings.

• Is the Extrapure Reverse Osmosis Water Unit single-use or reusable, and what does that mean for maintenance?

  The device is a reusable system, meaning it requires proper installation and ongoing maintenance to ensure consistent performance. Unlike single-use devices, it must be regularly serviced, cleaned, and inspected to meet purity standards for medical and laboratory applications.

• What regulatory pathway does the Extrapure Reverse Osmosis Water Unit follow, and how does that affect its use?

  The device follows the FDA’s 510(k) clearance pathway, classified as a Class II medical device under regulation number 876.5665. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for water purification systems in clinical and research settings.

• Are there different models or sizes available for the Extrapure Reverse Osmosis Water Unit, and if so, how do they differ?

  The provided data lists multiple registration numbers (e.g., 3005162618, 3017974963) under the product code FIP, which may indicate variations in models or configurations. However, specific differences in sizes, capacities, or features are not detailed in the data. Contact the manufacturer for precise model specifications.