# K191759: Medline Quick Switch Valve with ENFit Connector

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Dec 4, 2019 after 156 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: 1 generation back to K915171 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915171: Lopez Valve TM  II, Icu Medical, Inc. (1992) Summary page 4.

## Indications for use
The Medline Quick Switch Valve with ENFit Connector is a multi-port connector/valve closed system indicated for controlling fluid flow (nutrition, medication and water) between ENFit compatible devices, while reducing the frequency of disconnections between the associated ENFit devices. The Medline Quick Switch Valve with ENFit Connector can be used in pediatric (infants over 10kg, children, and adolescents) and adult patients, for up to 30 days.

Source page: https://510kreport.com/device/K191759
Methodology: https://510kreport.com/methodology