Cleared Traditional

K200557 - Enteral Feeding Syringes with ENfit connector (Model: 10 ml

Also marketed or referenced as:
60 ml control ring)

K200557 is an FDA 510(k) clearance for Enteral Feeding Syringes with ENfit con..., manufactured by Jiangsu Shenli Medical Production Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PNR cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K200557 · Jiangsu Shenli Medical Production Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
209d
Days
Class 2
Risk

K200557 is an FDA 510(k) clearance for the Enteral Feeding Syringes with ENfit connector (Model: 10 ml. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Jiangsu Shenli Medical Production Co., Ltd. (Changzhou City, CN). The FDA issued a Cleared decision on September 28, 2020 after a review of 209 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 Shenli Medical Production Co., Ltd. devices

FDA 510(k) Submission Details - K200557

510(k) Number K200557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date September 28, 2020
Days to Decision 209 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
78d slower than avg
Panel avg: 131d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNR Device Classification - Class 2, Special Controls

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

International Regulatory Consultants
Charlie Mack

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 34
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K200557.
ENFit Disposable Enteral Syringe
K203410 · Shantou Wealy Medical Instrument Co.,Ltd · Jun 2021
Oral/Enteral Syringe
K210621 · Ningbo Tianyi Medical Appliance Co., Ltd. · Apr 2021
Medline ENfit OTC Feeding Syringe
K202285 · Medline Industries, Inc. · Oct 2020
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