Hesung's Blood Donor Sets

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K841561 ↗

FDA Product Code

BRZ

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Hesung Scalp Vein Set

  Class II

  FDA 510(k) K841564 Active Cleared 17 Jul 1984

• Hesung's Hyperdermic Needles

  Class II

  FDA 510(k) K841565 Active Cleared 17 Jul 1984

• Hesung's Solution Infusion Sets

  Class II

  FDA 510(k) K841563 Active Cleared 17 Jul 1984

• Hesung Blood Transfusion Sets

  Class II

  FDA 510(k) K841562 Active Cleared 23 Jul 1984

• Hesung Disposable Syringe

  Class II

  FDA 510(k) K841566 Active Cleared 17 Jul 1984

• What is Hesung's Blood Donor Sets used for?

  Hesung's Blood Donor Sets are a Set, Blood Transfusion device intended for use in general hospital settings to facilitate blood transfusion procedures, as indicated by its classification under medical specialty General Hospital and device name.

• How is Hesung's Blood Donor Sets supplied or packaged?

  The device is supplied as a complete set for blood transfusion, though specific packaging details such as unit count or sterile barrier system are not provided in the authorization data; it is manufactured by Amkor Trading Co. for distribution in the United States.

• Is Hesung's Blood Donor Sets sterile and single-use?

  The device data does not specify sterility or single-use status; however, as a blood transfusion set, it is typically designed for single-use to prevent cross-contamination, but this inference cannot be confirmed from the provided information alone.

• What sizes or models are available for Hesung's Blood Donor Sets?

  No specific sizes, models, or reference numbers are listed in the device data beyond the product name 'Hesung's Blood Donor Sets' and the associated K841561 clearance; variations in size or configuration are not detailed in the provided specifications.

• How should Hesung's Blood Donor Sets be stored?

  Storage conditions are not specified in the device data; users should refer to the manufacturer's labeling for recommended storage temperature, humidity, and light exposure to maintain device integrity prior to use.