Cleared Traditional

K203613 - ENFit Reusable Enteral Syringe

K203613 is an FDA 510(k) clearance for ENFit Reusable Enteral Syringe, manufactured by Shantou Wealy Medical Instrument Co.,Ltd. The device is a Class 2 Gastroenterology & Urology device with product code PNR cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K203613 · Shantou Wealy Medical Instrument Co.,Ltd · Gastroenterology & Urology device
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Aug 2021
Decision
260d
Days
Class 2
Risk

K203613 is an FDA 510(k) clearance for the ENFit Reusable Enteral Syringe. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Shantou Wealy Medical Instrument Co.,Ltd (Shantou, CN). The FDA issued a Cleared decision on August 27, 2021 after a review of 260 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 Shantou Wealy Medical Instrument Co.,Ltd devices

FDA 510(k) Submission Details - K203613

510(k) Number K203613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2020
Decision Date August 27, 2021
Days to Decision 260 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
130d slower than avg
Panel avg: 130d · This submission: 260d
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

Shanghai Sungo Management Consulting Company Limited.
Eva Li

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 K203613.
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
K222155 · Jiangsu Caina Medical Co.,Ltd · Sep 2022
ENFit enteral syringes (NUTRIFIT)
K211661 · Pentaferte Italia S.R.L. · Feb 2022
Enteral Pump Syringe
K211593 · Jiangsu Caina Medical Co.,Ltd · Sep 2021
Oral/Enteral Syringe with ENFit connector
K211025 · Ningbo Tianyi Medical Appliance Co., Ltd. · Jun 2021
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