# K210971: EnteraLoc Flow

- Pathway: 510(k) (Traditional)
- Applicant: Vonco Products
- Decided: Aug 18, 2021 after 140 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: 9 generations back to K801558 (1980). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163586: Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector, Trovrx, Inc. Dba Trovita Health Science (2017) Summary page 5.
- K183540: Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL), Neomed, Inc. (2019) Summary page 5.

## Most influential descendants
- K223683: EnteraLoc Flow (2023), 0 descendants of its own

## Indications for use
The 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/K210971
Methodology: https://510kreport.com/methodology