# K970849: Enteral Nutrition 1000 ML/500ML

- Pathway: 510(k) (Traditional)
- Applicant: Medical Infusion Technologies, Inc.
- Decided: Aug 15, 1997 after 161 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902641 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902641: Rpi Enteral Feeding Bag 1000ML and 500ML, Ridge Products, Inc. (1990) Summary page 1.

## Indications for use
This product must be used only under a doctor’s prescription. Its indications for use are various medical situations wherein the patient is nourished by an appropriate formula by means of a tube passed into the stomach from the nasal passage. It is used for patients who for some reason are unwilling or unable to masticate or swallow food. The product is not for intravenous feeding.

Source page: https://510kreport.com/device/K970849
Methodology: https://510kreport.com/methodology