Cleared Traditional

Enteral Feeding Syringes with Enfit Connectors (K182649) - 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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PNR Enteral Syringes With Enteral Specific Connectors

All 23
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K182649.
Disposable Enteral Feeding Syringe with Enfit Connector
K193657 · Shinva Ande Healthcare Apparatus Co., Ltd. · Sep 2020
ENFit Oral / Enteral Syringe
K190502 · Jiangsu Caina Medical Co.,Ltd · Aug 2019
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
K183540 · Neomed, Inc. · Apr 2019
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
K181426 · Jiangsu Micsafe Medical Technology Co., Ltd. · Oct 2018
AMSure® Enteral Feeding Syringe with ENFit Tip
K171857 · Amsino International, Inc. · Mar 2018
Monoject Enteral Syringe with ENFit Connector
K161963 · Covidien · Sep 2016