# K242917: Enteral Drainage System, Enteral Medicine straw

- Pathway: 510(k) (Traditional)
- Applicant: HMC Premedical S.p.A.
- Decided: Jun 18, 2025 after 267 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- 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: 3 generations back to K132424 (2014). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142012: Farrell Valve System with Equilibrium Technology and Enfit Enteral Connectors, Corpak Medsystems (2014) Summary page 5.
- K190310: U Deliver Bolink ENFit Enteral Feeding Sets, U Deliver Medical, LLC (2019) Summary page 5.

## Indications for use
The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device. The Enteral Medicine Straw is intended for drawing and delivery of medicine to patients through an ENFit syringe.

Source page: https://510kreport.com/device/K242917
Methodology: https://510kreport.com/methodology