Mcgaw Fat Emulsion Set

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

510(k) Number

K820133 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Capd - Catheter Adapter

  Class II

  FDA 510(k) K831716 Active Cleared 24 Jun 1983

• Mixing Container

  Class II

  FDA 510(k) K843954 Active Cleared 28 Nov 1984

• Add-A-Vial Solution Transfer Device

  Class II

  FDA 510(k) K843639 Active Cleared 14 Jan 1985

• Mcgaw/Drop Watch Flow Monitor

  Class II

  FDA 510(k) K853549 Active Cleared 12 Nov 1985

• Accupro Enteral Feeding Pump

  Class II

  FDA 510(k) K841729 Active Cleared 1 Jun 1984

• Capd Exchange Set

  Class II

  FDA 510(k) K810600 Active Cleared 24 Mar 1981

See all devices from American Mcgaw →

• What is the McGraw Fat Emulsion Set used for?

  The McGraw Fat Emulsion Set is designed for the controlled intravenous administration of fat emulsions. Fat emulsions provide essential fatty acids and calories when oral nutrition is insufficient, making this set ideal for patients with severe malnutrition, trauma, or metabolic disorders where enteral feeding isn’t feasible. The set ensures sterile delivery while maintaining compatibility with standard medical tubing and connectors.

• Is the McGraw Fat Emulsion Set sterile and single-use?

  Yes, the McGraw Fat Emulsion Set is supplied as a sterile, single-use device. Sterility is critical for intravascular administration to prevent infection, and single-use ensures patient safety by eliminating cross-contamination risks between uses. Always follow sterile handling protocols before use.

• What components does the set include for administration?

  The set includes administration tubing, connectors, and a compatible infusion port. These components are designed to interface seamlessly with fat emulsion containers, enabling precise and controlled infusion into the bloodstream. The tubing and connectors are engineered for medical-grade use to maintain sterility and compatibility.

• How should the McGraw Fat Emulsion Set be stored?

  The set must be stored according to sterile medical device protocols to prevent contamination. Keep it in its original packaging until ready for use, and avoid exposure to moisture, extreme temperatures, or direct sunlight. Proper storage ensures the device remains sterile and functional for its intended single-use application.

• What regulatory clearance does the McGraw Fat Emulsion Set hold?

  The McGraw Fat Emulsion Set holds FDA 510(k) clearance under the determination of Substantially Equivalent (K820133). It was reviewed by the General Hospital Advisory Committee and classified under product code FPA. This clearance confirms the device meets regulatory standards for safety and effectiveness in its intended use.