Cleared Traditional

K202748 - Enteral Feeding Catheter

K202748 is an FDA 510(k) clearance for Enteral Feeding Catheter, manufactured by Medcaptain Life Science Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K202748 · Medcaptain Life Science Co., Ltd. · Gastroenterology & Urology device
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Apr 2021
Decision
200d
Days
Class 2
Risk

K202748 is an FDA 510(k) clearance for the Enteral Feeding Catheter. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medcaptain Life Science Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 9, 2021 after a review of 200 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 Medcaptain Life Science Co., Ltd. devices

FDA 510(k) Submission Details - K202748

510(k) Number K202748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2020
Decision Date April 09, 2021
Days to Decision 200 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
70d slower than avg
Panel avg: 130d · This submission: 200d
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 345
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K202748.
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ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
K203133 · Envizion Medical , Ltd. · Mar 2021
TubeClear System
K200646 · Actuated Medical, Inc. · Dec 2020
Nutriglide(TM) Nasal Feeding Tube
K202539 · Applied Medical Technology, Inc. · Oct 2020