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Nutricare Enfutec 1000 Enteral Feeding Pump

by Clinical Systems, Inc.

510(k) K901458

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 NumberK901458 Date22 Jun 1990ClearedStatusActive

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  • Withdrawn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, 27 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 Nutricare Enfutec 1000 Enteral Feeding Pump is a device designed for enteral feeding administration. It is classified as an infusion pump specifically for enteral nutrition delivery.

This device is manufactured by Clinical Systems, Inc. and is supplied as a Class II medical device with FDA 510(k) clearance K901458. The pump is intended for use in general hospital settings and is registered under product code LZH.

Other devices from Clinical Systems, Inc.

Questions

AI-generated answers, 27 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 is the Nutricare Enfutec 1000 Enteral Feeding Pump used for?

    The Nutricare Enfutec 1000 is a device designed for enteral feeding administration, specifically for delivering enteral nutrition in general hospital settings. It is classified as an infusion pump for this purpose.

  • Is the Nutricare Enfutec 1000 a single-use or reusable device?

    The device data does not specify whether the Nutricare Enfutec 1000 is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

  • What is the regulatory status of the Nutricare Enfutec 1000 Enteral Feeding Pump?

    The Nutricare Enfutec 1000 Enteral Feeding Pump is a Class II medical device with FDA 510(k) clearance K901458, classified as substantially equivalent to predicate devices for enteral nutrition delivery in hospital settings.

  • What sizes or models of the Nutricare Enfutec 1000 are available?

    The device data does not specify different sizes or models of the Nutricare Enfutec 1000 Enteral Feeding Pump. The information provided refers to a single device model with the product code LZH.