Cleared Traditional

K240039 - Enteral Feeding Sets

K240039 is an FDA 510(k) clearance for Enteral Feeding Sets, manufactured by Hangzhou Primecare Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K240039 · Hangzhou Primecare Medical Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K240039

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.

KNT Device Classification - Class 2, Special Controls

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 347
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K240039.
Stylus
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ViSiGi LUX (5332)
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Endolumik Gastric Calibration Tube M Series (EGCT36M)
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ViSiGi 3D Gastric Sizing Tube
K234145 · Boehringer Laboratories · Jan 2024
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846 · Applied Medical Technology, Inc. · Dec 2023