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Flexiflo Six Enteral Nutrition Pump Set

by Abbott Laboratories 510(k)

Active United States

510(k) K943240

Overview

The Flexiflo Six Enteral Nutrition Pump Set is a volumetric infusion pump designed for the administration of enteral nutrition. It delivers measured volumes of enteral formula via a specially constructed administration set, including a cassette with bellows to ensure precise fluid delivery. This device is intended for use in clinical settings where controlled enteral feeding is required, such as hospitals or home care environments.

The pump operates using either AC power or battery and includes a fluid delivery system with integrated safety alarms. Supplied as a single-use device, it is regulated under FDA 510(k) clearance (K943240) and is classified under product code KNT. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality, ensuring safe and accurate enteral nutrition delivery.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943240 Date13 Apr 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0888-2007 FDA Unclassified (pre-2012) initiated 2 May 2007

    The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.

Specification

510(k)

510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Flexiflo Six Enteral Nutrition Pump Set used for?

    The Flexiflo Six Enteral Nutrition Pump Set is designed for administering measured volumes of enteral formula in clinical settings where controlled feeding is required. It uses a cassette with bellows to deliver precise fluid amounts, making it ideal for patients needing regulated enteral nutrition in hospitals or home care environments.

  • Is the Flexiflo Six Enteral Nutrition Pump Set single-use or reusable?

    The Flexiflo Six Enteral Nutrition Pump Set is supplied as a single-use device. This ensures sterility and safety for each patient, reducing the risk of contamination or cross-infection between uses.

  • What power sources can the Flexiflo Six Enteral Nutrition Pump Set use?

    The device operates using either AC power or a battery, providing flexibility for use in different clinical environments, including hospitals and home care settings.

  • How should the Flexiflo Six Enteral Nutrition Pump Set be stored?

    Storage and handling must follow the manufacturer’s guidelines to maintain sterility and functionality. Proper storage ensures the device remains effective and safe for use when needed.

  • What safety features does the Flexiflo Six Enteral Nutrition Pump Set include?

    The pump includes integrated safety alarms to monitor and alert users to potential issues during enteral nutrition delivery, enhancing patient safety during use.