Cleared Traditional

K200082 - BD Univia RightFit Enteral Extension Se...

K200082 is the FDA 510(k) clearance for BD Univia RightFit Enteral Extension Se... by Mps Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K200082 · Mps Medical, Inc. · Gastroenterology & Urology device
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Jul 2020
Decision
197d
Days
Class 2
Risk

K200082 is an FDA 510(k) clearance for the BD Univia RightFit Enteral Extension Sets and Transitional Adapters. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Mps Medical, Inc. (Brea, US). The FDA issued a Cleared decision on July 30, 2020 after a review of 197 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 Mps Medical, Inc. devices

Submission Details

510(k) Number K200082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2020
Decision Date July 30, 2020
Days to Decision 197 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
67d slower than avg
Panel avg: 130d · This submission: 197d
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 K200082.
Gabriel 3 Way EnFit Valve
K201741 · Syncro Medical Innovations, Inc. · Nov 2020
Nutricare Clear-ISOSAF Nasogastric Feeding Tube
K202357 · Three Circles Consulting Limited · Oct 2020
Vesco Medical Extension Feeding Set
K192991 · Vesco Medical, LLC · Aug 2020
Medline Quick Switch Valve with ENFit Connector
K191759 · Medline Industries, Inc. · Dec 2019
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