Cleared Traditional

K190923 - Salem Sump Dual Lumen Stomach Tube with...

K190923 is the FDA 510(k) clearance for Salem Sump Dual Lumen Stomach Tube with... by Cardinalhealth. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K190923 · Cardinalhealth · Gastroenterology & Urology device
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Nov 2019
Decision
212d
Days
Class 2
Risk

K190923 is an FDA 510(k) clearance for the Salem Sump Dual Lumen Stomach Tube with ENFit Connection. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Cardinalhealth (Mansfield, US). The FDA issued a Cleared decision on November 7, 2019 after a review of 212 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 Cardinalhealth devices

Submission Details

510(k) Number K190923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2019
Decision Date November 07, 2019
Days to Decision 212 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
82d slower than avg
Panel avg: 130d · This submission: 212d
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 K190923.
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
K200082 · Mps Medical, Inc. · Jul 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
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
K190414 · Moss Tubes, Inc. · Jun 2019
U Deliver Bolink ENFit Enteral Feeding Sets
K190310 · U Deliver Medical, LLC · May 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787 · Cedic S.R.L. · Apr 2019