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Enteral Expres Pump Unit, Enteral Expres Giving Sets

by Debio Tech SA

510(k) K011868

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011868 Date4 Sep 2001ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZH
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Enteral Expres Pump Unit is a device designed for the delivery of standard enteral nutrition fluids to patients in hospital and alternate care settings. It consists of a pump unit and associated giving sets that work together to provide controlled enteral fluid delivery.

The device is supplied as a class II medical product with FDA 510(k) clearance (K011868) and is regulated under product code LZH. It is intended for use in general hospital settings and is manufactured by Debio Tech SA. The device includes various model numbers and sizes as specified in the registration details.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the Enteral Expres Pump Unit serve?

    It is designed to deliver standard enteral nutrition fluids to patients, allowing controlled infusion of formula in both hospital and alternate care environments. This ensures patients receive consistent nutritional support when oral intake is insufficient.

  • How is the system supplied to the user?

    The product is supplied as a complete system that includes the pump unit together with compatible giving sets. The combined package enables immediate setup for enteral feeding without needing separate components.

  • Is the Enteral Expres Pump Unit intended for single‑use or multiple‑use?

    The device is a Class II medical product intended for repeated clinical use. The pump unit is reusable according to manufacturer instructions, while the giving sets are typically disposable to maintain sterility for each patient.

  • What model numbers or sizes are available for this pump system?

    The registration indicates that the system is offered in various model numbers and sizes, though specific identifiers are not listed in the excerpt. Different models allow selection based on patient volume requirements and clinical setting.

  • What regulatory clearance does the Enteral Expres Pump Unit have?

    It has FDA 510(k) clearance (K011868) under product code LZH, classified as a Class II device. This clearance confirms that the pump is substantially equivalent to a legally marketed predicate device for enteral nutrition delivery.