# K190310: U Deliver Bolink ENFit Enteral Feeding Sets

- Pathway: 510(k) (Traditional)
- Applicant: U Deliver Medical, LLC
- Decided: May 31, 2019 after 108 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: 2 generations back to K132424 (2014). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170555: U Deliver Bolink ENFit Enteral Feeding Sets, U Deliver Medical, LLC (2017) Summary page 5.

## Most influential descendants
- K242917: Enteral Drainage System, Enteral Medicine straw (2025), 0 descendants of its own
- K223683: EnteraLoc Flow (2023), 0 descendants of its own

## Indications for use
The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

Source page: https://510kreport.com/device/K190310
Methodology: https://510kreport.com/methodology