Cleared Traditional

Enteral Feeding Sets (K240039) - FDA 510(k) Clearance

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

K240039 · Hangzhou Primecare Medical Co., Ltd. · Gastroenterology & Urology device
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Apr 2024
Decision
103d
Days
Class 2
Risk

K240039 is an FDA 510(k) clearance for the Enteral Feeding Sets. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hangzhou Primecare Medical Co., Ltd. (Hang Zhou, CN). The FDA issued a Cleared decision on April 17, 2024 after a review of 103 days - within the typical 510(k) review window.

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 Hangzhou Primecare Medical Co., Ltd. devices

Submission Details

510(k) Number K240039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2024
Decision Date April 17, 2024
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K240039.
Stylus
K233591 · Degania Silicone , Ltd. · May 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039 · Reshape Lifesciences · May 2024
ViSiGi LUX (5332)
K234033 · Boehringer Laboratories, LLC · May 2024
Endolumik Gastric Calibration Tube M Series (EGCT36M)
K240069 · Endolumik · Feb 2024
ViSiGi 3D Gastric Sizing Tube
K234145 · Boehringer Laboratories · Jan 2024
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846 · Applied Medical Technology, Inc. · Dec 2023