# K223683: EnteraLoc Flow

- Pathway: 510(k) (Traditional)
- Applicant: Vonco Products
- Decided: Jul 10, 2023 after 214 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: 10 generations back to K801558 (1980). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210971: EnteraLoc Flow, Vonco Products (2021) Summary page 4.
- K190310: U Deliver Bolink ENFit Enteral Feeding Sets, U Deliver Medical, LLC (2019) Summary page 5.

## Indications for use
The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.

Source page: https://510kreport.com/device/K223683
Methodology: https://510kreport.com/methodology