Enteroport Nutrition Pump

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841827 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Diatek, Inc. →

• Is the Enteroport Nutrition Pump designed for single-use or can it be reused in clinical settings?

  The Enteroport Nutrition Pump is explicitly described as a reusable medical instrument, meaning it is intended for repeated use in both inpatient and outpatient environments. Since it is classified as a reusable device, proper cleaning, maintenance, and sterilization protocols for the pump itself (not the feeding tubes) must be followed per manufacturer guidelines to ensure safe and effective operation.

• What types of feeding tubes is the Enteroport Nutrition Pump compatible with, and how is it programmed for use?

  The Enteroport Nutrition Pump is designed for controlled administration of enteral nutrition via gastric or intestinal feeding tubes, though the specific tube compatibility (e.g., size, type) is not detailed in the provided data. It delivers programmable flow rates of liquid diets, allowing clinicians to set precise feeding regimens for patients requiring long-term nutritional support. The pump’s design ensures accurate and consistent delivery, but the exact programming interface or user controls are not specified.

• Does the Enteroport Nutrition Pump require sterile handling, or is it intended for non-sterile setup and maintenance?

  The pump itself is operated in non-sterile conditions for setup and maintenance, as stated in the description. However, the feeding tubes and associated accessories connected to it may require sterile handling, depending on clinical protocols and the patient’s condition. Sterility considerations should align with standard enteral feeding practices to minimize infection risk.

• What regulatory pathway was used for FDA clearance of the Enteroport Nutrition Pump, and what does this mean for its use in hospitals?

  The Enteroport Nutrition Pump received FDA clearance through the 510(k) pathway (K841827), which confirms it meets U.S. medical device standards for infusion systems. This classification as a Class II device indicates it undergoes additional controls beyond general controls, ensuring its safety and effectiveness for controlled enteral nutrition delivery in both inpatient and outpatient settings. The clearance does not impose MRI safety restrictions or single-use requirements.