Cleared Traditional

K150711 - Salem Sump Dual Lumen Stomach Tube with...

K150711 is the FDA 510(k) clearance for Salem Sump Dual Lumen Stomach Tube with... by Covidien. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K150711 · Covidien · Gastroenterology & Urology device
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Oct 2015
Decision
203d
Days
Class 2
Risk

K150711 is an FDA 510(k) clearance for the Salem Sump Dual Lumen Stomach Tube with Multi-functional Port. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on October 8, 2015 after a review of 203 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 Covidien devices

Submission Details

510(k) Number K150711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2015
Decision Date October 08, 2015
Days to Decision 203 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
73d slower than avg
Panel avg: 130d · This submission: 203d
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 K150711.
CONOD Enteral Feeding Sets
K181276 · Conod Medical Co., Limited · Jul 2018
Medline ENFit Syringe
K160642 · Medline Industries, Inc. · Nov 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
K161003 · Boston Scientific Corporation · Jun 2016
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
K150084 · Covidien · Jul 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
K150679 · Boston Scientific Corp · May 2015
Medline Enteral Feeding Sets
K150286 · Medline Industries, Inc. · Apr 2015