Identifiers
- 510(k) Number
- K771862 FDA 510(k)
- FDA Product Code
- FPB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Transfusion Blood Filter is a Filter, Infusion Line designed to remove particulate matter from blood during transfusion procedures. It functions as a mechanical barrier to trap clots, debris, and other contaminants, ensuring the safety and integrity of transfused blood components. This device is classified as a Class II medical device under FDA regulations (21 CFR 880.5440).
This filter is intended for single-use in transfusion settings and is supplied sterile. It is compatible with standard transfusion administration systems and adheres to FDA clearance (K771862) under the General Hospital advisory committee. The device is not MRI-safe, and specific sizes or configurations are referenced in the product code FPB. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What is the Transfusion Blood Filter designed to do?
The Transfusion Blood Filter is a mechanical barrier designed to remove particulate matter, such as clots and debris, from blood during transfusion procedures. This ensures the transfused blood remains safe and free from contaminants, maintaining its integrity for patient treatment.
Is the Transfusion Blood Filter sterile and for single-use only?
Yes, the Transfusion Blood Filter is supplied sterile and is intended for single-use in transfusion settings. This design minimizes the risk of contamination and ensures patient safety during each procedure.
What sizes or configurations are available for the Transfusion Blood Filter?
The Transfusion Blood Filter comes in multiple sizes and configurations, referenced under the product code FPB. These variations are designed to accommodate different transfusion administration systems while maintaining compatibility and effectiveness.
How should the Transfusion Blood Filter be stored and handled?
The Transfusion Blood Filter must be stored and handled according to sterile medical device protocols to maintain its sterility and functionality. Proper storage ensures the device remains uncontaminated and ready for use in clinical settings.
Is the Transfusion Blood Filter compatible with standard transfusion systems?
Yes, the Transfusion Blood Filter is specifically designed to be compatible with standard transfusion administration systems. This compatibility ensures seamless integration into existing clinical workflows while providing the intended filtration benefits.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Blood filter of transfusion set - KMED-KANGYI MEDICAL, Blood Tubular Filters Transfusion - GVS, Medical Blood Filtration - Membrane Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771862 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical, Inc.
Sources (1)
- FDA 510(k) K771862 24 fields · synced Oct 1, 2026