Hemo-Ro

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

510(k) Number

K771763 ↗

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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  Class II

  FDA 510(k) K023892 Active Cleared 17 Jan 2003

• Waters 740 Data Module-Plotter Integrator

  Class I

  FDA 510(k) K850272 Active Cleared 6 Mar 1985

• Waters(Tm) 996 Pda

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• Ultra-Free

  Class I

  FDA 510(k) K790445 Active Cleared 28 Jun 1979

• Millipore Ivex Int Filter Unit

  Class II

  FDA 510(k) K832952 Active Cleared 4 Oct 1983

See all devices from Millipore Corp. →

• What types of clinical environments is the HEMO-RO Water Purification System designed for, and how does it support those settings?

  The HEMO-RO Water Purification System is specifically designed for clinical and research settings, particularly in gastroenterology and urology environments. It uses reverse osmosis technology to produce high-purity water, which is critical for procedures requiring sterile or contaminant-free water, such as irrigation, dialysis, or laboratory testing. Its FDA clearance under product code FIP (Water Purification) reflects its role in ensuring water quality for medical applications.

• Is the HEMO-RO system reusable, and what maintenance is required to keep it functioning properly?

  Yes, the HEMO-RO is a reusable device, meaning it is built for repeated use in clinical settings with proper installation and maintenance. To maintain optimal performance, it must be cleaned, serviced, and calibrated according to the manufacturer’s guidelines—Millipore Corp. (based in Mchenry, IL). Regular upkeep ensures consistent water purification and prevents contamination buildup, which is essential for medical-grade applications.

• How do I determine if my facility’s water purification needs align with the HEMO-RO’s capabilities?

  The HEMO-RO is designed to produce high-purity water suitable for medical and laboratory use, removing contaminants and minerals to meet strict quality standards. If your facility requires purified water for procedures like irrigation in gastroenterology or urology, or for laboratory applications, this system is a viable option. Its reverse osmosis technology ensures compliance with standards for water purity in regulated clinical settings.

• What regulatory pathway was used for the FDA clearance of the HEMO-RO, and when was it approved?

  The HEMO-RO Water Purification System received FDA 510(k) clearance under the Traditional 510(k) pathway, with a decision date of July 6, 1984. The clearance (K841403) was granted as substantially equivalent to a predicate device, confirming its compliance with FDA regulations for water purification systems (product code FIP). This pathway ensures the device meets safety and effectiveness standards for its intended clinical use.