Enfuse Enternal Administration Set & Pump Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871019 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Entube Tm, Enteral Feeding Tube

  Class II

  FDA 510(k) K861427 Active Cleared 18 Jul 1986

• Entainer(Tm) Enteral Feeding Container

  Class II

  FDA 510(k) K890430 Active Cleared 2 Jun 1989

• Top-Port Enteral Feeding Bag and Preattached Sets

  Class II

  FDA 510(k) K861552 Active Cleared 16 Jun 1986

• Entube-Meer and Meer Feeding Tube Bridle System

  Class II

  FDA 510(k) K873343 Active Cleared 7 Dec 1987

• Gilsdorf Percu. Endo.-Peg & Percu. Flouro.-Pfg

  Class II

  FDA 510(k) K891371 Active Cleared 3 Aug 1989

• Entech Enteral Pump and Set

  Class II

  FDA 510(k) K873444 Active Cleared 2 Nov 1987

• What types of enteral access routes is the Enfuse Enteral Administration Set & Pump Set compatible with?

  The Enfuse Enteral Administration Set & Pump Set is designed for use with nasogastric, orogastric, or gastrostomy tubes, as it delivers controlled, continuous infusion of enteral nutrition or fluids directly into the gastrointestinal tract. Its compatibility with these access routes makes it suitable for patients requiring enteral feeding through these common pathways.

• Is the Enfuse Enteral Administration Set & Pump Set intended for single-use or can it be reused?

  The Enfuse Enteral Administration Set & Pump Set is explicitly intended for single-use only. It is supplied sterile and requires no additional preparation before use, ensuring patient safety and compliance with medical device standards. Reuse is not recommended or supported by the manufacturer.

• How is the Enfuse Enteral Administration Set & Pump Set packaged and what does it include?

  The set comes as a sterile, single-use package and includes a 1000ml feeding bag equipped with an ENFit transfer adapter, ensuring seamless compatibility with standard enteral feeding systems. The adapter simplifies the transfer process, reducing the risk of contamination or spillage during setup.

• What regulatory pathway did the Enfuse Enteral Administration Set & Pump Set follow for FDA clearance?

  The device was cleared via an FDA 510(k) submission (K871019) filed in 1987, with a decision of Substantially Equivalent by the Gastroenterology and Urology Advisory Committee. This classification (product code KNT) confirms its compliance with U.S. regulatory standards for enteral administration devices.