Cleared Traditional

K191759 - Medline Quick Switch Valve with ENFit C...

K191759 is the FDA 510(k) clearance for Medline Quick Switch Valve with ENFit C... by Medline Industries, Inc.. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K191759 · Medline Industries, Inc. · Gastroenterology & Urology device
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Dec 2019
Decision
156d
Days
Class 2
Risk

K191759 is an FDA 510(k) clearance for the Medline Quick Switch Valve with ENFit Connector. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 4, 2019 after a review of 156 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K191759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2019
Decision Date December 04, 2019
Days to Decision 156 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 36
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K191759.
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BD Univia RightFit Enteral Extension Sets and Transitional Adapters
K200082 · Mps Medical, Inc. · Jul 2020
Gabriel Feeding Tube with Balloon, and EnFit Connector
K191784 · Syncro Medical Innovations, Inc. · Nov 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923 · Cardinalhealth · Nov 2019
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
K190414 · Moss Tubes, Inc. · Jun 2019