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Enteral Nutrition 1000 ML/500ML

by Medical Infusion Technologies, Inc.

510(k) K970849

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 NumberK970849 Date15 Aug 1997ClearedStatusActive

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  • Withdrawn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
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 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 Nutrition 1000 Ml/500ml is a device for dispensing liquid nutrients and medication, consisting of a reservoir bag and tubing for delivery of formula into a nasogastric tube. It operates via gravity and has no electronic or automated components. This device is used for enteral nutrition, providing a means to deliver necessary nutrients to patients. The device is a gravity-fed system, allowing for the controlled delivery of liquid nutrients and medication.

The Enteral Nutrition 1000 Ml/500ml is supplied in sizes 1000 ml and 500ml. It is used in clinical or home settings under physician prescription. The device has been cleared by the FDA, with a 510(k) clearance number of K970849. The device is intended for single-use and is not suitable for MRI. Storage and handling instructions are not provided, but it is recommended to follow standard medical device storage procedures.

Other devices from Medical Infusion Technologies, Inc.

Questions

AI-generated answers, 6 Oct 2026

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

  • What sizes are available for the Enteral Nutrition system?

    The system is offered in two volume options: a 1000 ml reservoir bag and a smaller 500 ml bag. The choice allows clinicians to match the volume to the patient’s nutritional needs and the expected duration of therapy, reducing waste and handling.

  • Is the Enteral Nutrition device intended for single or multiple use?

    It is intended for single‑use only. After the bag and tubing have been used to deliver formula, they must be discarded to maintain sterility and prevent cross‑contamination between patients.

  • Can the Enteral Nutrition bag be used in an MRI environment?

    No, the device is not suitable for MRI. Although it contains no electronic components, manufacturers advise against exposure to the magnetic field to avoid any unforeseen interactions or safety concerns.

  • How is the feeding solution delivered with this device?

    Delivery relies on gravity; the bag is hung above the patient and the formula flows through the tubing into a nasogastric tube. This simple mechanism provides controlled, continuous infusion without the need for pumps or power sources.

  • What regulatory clearance does the Enteral Nutrition system have?

    The product received traditional 510(k) clearance from the FDA (clearance number K970849) indicating it is substantially equivalent to a legally marketed predicate device for enteral nutrition delivery.