Filter Unit, Single Use

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

510(k) Number

K770703 ↗

FDA Product Code

FPB

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Millex Vv, Gv, and Hv Syringe Filter Units

  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

  Class I

  FDA 510(k) K924347 Active Cleared 11 Dec 1992

• Light Diagnostics Hsv 1/2 Typing Dfa Kit

  Class II

  FDA 510(k) K081527 Active Cleared 1 Apr 2009

• 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 is the primary purpose of the Millipore Filter Unit, Single Use?

  The Millipore Filter Unit, Single Use, is designed to remove particulate matter from fluids during infusion therapy. This ensures the sterility and safety of administered fluids in hospital settings by preventing contamination through its filtration technology. It is specifically intended for use in infusion lines where maintaining fluid purity is critical.

• How is the Filter Unit supplied, and what are the handling requirements?

  The Filter Unit is supplied sterile and intended exclusively for single-use applications. This means it is pre-sterilized by the manufacturer and should not be reprocessed or reused. To maintain sterility, it must be handled under aseptic conditions—meaning it should be kept free from contamination before, during, and after use. Always follow manufacturer guidelines for proper handling and storage.

• Is the Filter Unit reusable, and if not, why?

  No, the Filter Unit is designed for single-use only. The rationale behind this is to eliminate the risk of cross-contamination between patients and to ensure consistent performance. Reusing a single-use medical device could compromise sterility, introduce microbial contamination, or reduce filtration efficacy, potentially compromising patient safety. The device’s design and regulatory classification reflect this restriction.

• What storage instructions should be followed for the Filter Unit?

  The Filter Unit should be stored according to the manufacturer’s guidelines to preserve its integrity until use. This typically includes keeping it in its original, sealed packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the device remains sterile and functional, ready for immediate clinical use when needed.

• What regulatory approval does the Millipore Filter Unit hold, and how does this affect its use?

  The Filter Unit holds FDA 510(k) clearance under the reference number K770703, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This approval confirms that the device meets applicable regulatory standards for safety and effectiveness. Clinicians and users should rely on this clearance as assurance of the device’s compliance with FDA requirements, though adherence to manufacturer instructions remains essential for proper use.