# K240039: Enteral Feeding Sets

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Primecare Medical Co., Ltd.
- Decided: Apr 17, 2024 after 103 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: 7 generations back to K851539 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181276: CONOD Enteral Feeding Sets, Conod Medical Co., Limited (2018) Summary page 5.

## Indications for use
Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.

Source page: https://510kreport.com/device/K240039
Methodology: https://510kreport.com/methodology