Cleared Traditional

K213174 - Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 49
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K213174.
Percutaneous Endoscopic Gastrostomy (PEG) Kit
K254170 · Degania Silicone , Ltd. · Mar 2026
Enteral Drainage System, Enteral Medicine straw
K242917 · Hmc Premedical S.P.A. · Jun 2025
Extension Feeding Set with ENFit™ Connectors
K250481 · SKY Medical, a.s. · Apr 2025
Disposable Enteral Feeding Sets
K240052 · Beijing L&Z Medical Technology Development Co., Ltd. · Jul 2024
Mobility+ Enteral Feeding System OTC
K233034 · Rockfield Medical · Apr 2024
Feeding Tube
K222773 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023