Cleared Traditional

K190502 - ENFit Oral / Enteral Syringe

K190502 is the FDA 510(k) clearance for ENFit Oral / Enteral Syringe by Jiangsu Caina Medical Co.,Ltd. It is a Class 2 Gastroenterology & Urology device (product code PNR) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K190502 · Jiangsu Caina Medical Co.,Ltd · Gastroenterology & Urology device
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Aug 2019
Decision
158d
Days
Class 2
Risk

K190502 is an FDA 510(k) clearance for the ENFit Oral / Enteral Syringe. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on August 6, 2019 after a review of 158 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 Jiangsu Caina Medical Co.,Ltd devices

Submission Details

510(k) Number K190502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2019
Decision Date August 06, 2019
Days to Decision 158 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
28d slower than avg
Panel avg: 130d · This submission: 158d
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 K190502.
Medline ENfit OTC Feeding Syringe
K202285 · Medline Industries, Inc. · Oct 2020
Enteral Feeding Syringes with ENfit connector (Model: 10 ml
K200557 · Jiangsu Shenli Medical Production Co., Ltd. · Sep 2020
Disposable Enteral Feeding Syringe with Enfit Connector
K193657 · Shinva Ande Healthcare Apparatus Co., Ltd. · Sep 2020
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
Enteral Feeding Syringes with Enfit Connectors
K182649 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 2018
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