📋 FDA Reference
Interface 20 Micron Transfusion Bld F
Abbott Laboratories
Summary: The Interface 20 Micron Transfusion Bld F is a medical device used in blood transfusion procedures. It is primarily utilized by hematologists and transfusion specialists to ensure the safe and effective delivery of blood products.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K810855 ↗
Decision Date ?
April 21, 1981
Product Code ?
CAK
Device Class ?
Class 2
Evidence ?
0 studies
The Interface 20 Micron Transfusion Bld F was cleared through the FDA 510k pathway on April 21, 1981. Manufactured by Abbott Laboratories, it is classified as a Class 2 device under product code CAK.
What It Is
The Interface 20 Micron Transfusion Bld F is a specialized filter used in blood transfusion procedures to remove microaggregates and other potential contaminants from blood products. This ensures that transfused blood is as safe as possible for the recipient, reducing the risk of complications such as embolism or immune reactions. The device operates by filtering blood through a 20-micron mesh, capturing unwanted particles while allowing the passage of essential blood components.
FDA-Cleared Indications
- Filtration of blood and blood components during transfusion.
- Removal of microaggregates and particulate matter from transfused blood products.
- Use as part of a compatible blood-transfusion administration set.
Clinical Applications
- Filtering whole blood during transfusion.
- Filtering red blood cell components during transfusion.
- Filtering platelet components when compatible with the labeled transfusion setup.
- Use in hospital transfusion services and hematology settings where particulate filtration is indicated.
Practical Considerations
- The device uses a 20-micron filter and should be used only with compatible blood products, tubing, and administration equipment.
- Prime the filter and tubing according to the instructions for use and institutional protocol to reduce air entry and maintain appropriate flow.
- Inspect the filter, package, connections, and expiration date before use; do not use if damaged or contaminated.
- Monitor flow, pressure, clotting, leakage, and patient response during transfusion. Replace the set according to the labeling and blood-bank policy rather than reusing it.
- This is not an implantable device and has no MRI-related implant safety designation; MRI compatibility is generally not relevant after the external transfusion setup is removed.
Frequently Asked Questions
What is Interface 20 Micron Transfusion Bld F used for?
It is used to filter blood products during transfusions, removing microaggregates and contaminants to ensure patient safety.
What specialties typically use this device?
Hematology and transfusion medicine specialists commonly use this device, particularly in hospital settings.
What are the FDA-cleared indications?
The device is indicated for filtering blood products during transfusions to prevent complications from microaggregates and contaminants.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.