Cleared Traditional

K182649 - Enteral Feeding Syringes with Enfit Connectors (FDA 510(k) Clearance)

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

K182649 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Gastroenterology & Urology device

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Nov 2018

Decision

46d

Days

Class 2

Risk

K182649 is an FDA 510(k) clearance for the Enteral Feeding Syringes with Enfit Connectors. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Jiangsu Kangbao Medical Equipment Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on November 9, 2018 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jiangsu Kangbao Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number	K182649 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 2018
Decision Date	November 09, 2018
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

84d faster than avg

Panel avg: 130d · This submission: 46d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	PNR Enteral Syringes With Enteral Specific Connectors
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 876.5980
Definition	Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors.

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.