Cleared Traditional

K213174 - Salem Sump Silicone Dual Lumen Stomach ...

K213174 is the FDA 510(k) clearance for Salem Sump Silicone Dual Lumen Stomach ... by Cardinalhealth. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K213174 · Cardinalhealth · Gastroenterology & Urology device
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May 2022
Decision
233d
Days
Class 2
Risk

K213174 is an FDA 510(k) clearance for the Salem Sump Silicone 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 (Waukegan, US). The FDA issued a Cleared decision on May 19, 2022 after a review of 233 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.

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Submission Details

510(k) Number K213174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date May 19, 2022
Days to Decision 233 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
103d slower than avg
Panel avg: 130d · This submission: 233d
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 K213174.
EnteraLoc Flow
K223683 · Vonco Products · Jul 2023
Mobility+ Enteral Feeding System
K222678 · Rockfield Medical · Oct 2022
Nasogastric Feeding Tubes - ENFit Port - PVC
K213258 · Cair Lgl · Jun 2022
Entuit PEG, Entuit PEGJ
K213356 · Wilson-Cook Medical, Inc. · Jan 2022
Enteral Feeding Set
K210854 · Kb Medical (Group), Inc. · Nov 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
K210598 · Cair Lgl · Nov 2021