Norfolk Medical Butterfly Infusion Set

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

510(k) Number

K870188 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Norfolk Medical NorPort

  Class II

  FDA 510(k) K871209 Active Cleared 24 Jun 1987

• Norfolk Medical Peritoneal-Access Port

  Class III

  FDA 510(k) K854593 Active Cleared 4 Feb 1986

• Vascular Access Port Changes in Mater LJT

  Class II

  FDA 510(k) K840788 Active Cleared 24 Apr 1984

• TidalPort-AP Implantable Apheresis Vascular Access Port

  Class II

  FDA 510(k) K192291 Active Cleared 20 Aug 2020

• Vascular-Access-Port LJT

  Class II

  FDA 510(k) K830000 Active Cleared 1 Mar 1983

• Norfolk Omega Port-LP Subcutaneous Implanted

  Class II

  FDA 510(k) K942784 Active Cleared 2 May 1995

See all devices from Norfolk Medical Products, Inc. →

• What types of clinical settings is the Norfolk Medical Butterfly Infusion Set approved for use in?

  The device is cleared for use in general hospital environments, including hospitals and outpatient care settings. Its butterfly needle design is specifically suited for administering fluids, medications, or nutrients into small veins, making it ideal for short-term infusions in these clinical areas.

• Is the Norfolk Medical Butterfly Infusion Set intended for repeated use, or is it designed for single-use only?

  The device is explicitly intended for single-use only. This ensures patient safety by maintaining sterility and reducing the risk of contamination or infection during infusion procedures.

• How is the Norfolk Medical Butterfly Infusion Set supplied, and what does that mean for its handling?

  The infusion set is supplied sterile, meaning it is pre-sterilized and packaged to prevent contamination before use. This allows clinicians to rely on its cleanliness immediately upon opening, minimizing the need for additional sterilization steps before administration.

• What regulatory pathway was followed for the FDA clearance of this infusion set, and what does that imply about its safety standards?

  The device underwent a traditional 510(k) clearance process through the FDA, with a decision classification of *Substantially Equivalent* to a predicate device. This means its safety and performance were compared to an existing, legally marketed device, ensuring it meets established regulatory standards for peripheral infusion sets in general hospital use.