# K102712: Med Gravity Set, Imed Pump Set

- Pathway: 510(k) (Traditional)
- Applicant: Imed Technology, Inc.
- Decided: Dec 16, 2011 after 452 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The devices in the iMed Technology Enteral Feeding Set family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense the feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food containing. These devices are to be issued by prescription only.

Source page: https://510kreport.com/device/K102712
Methodology: https://510kreport.com/methodology