Cleared Traditional

K183540 - 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) (FDA 510(k) Clearance)

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

K183540 · Neomed, Inc. · Gastroenterology & Urology device
Apr 2019
Decision
131d
Days
Class 2
Risk

K183540 is an FDA 510(k) clearance for the Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Ora.... Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Neomed, Inc. (Woodstock, US). The FDA issued a Cleared decision on April 30, 2019 after a review of 131 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K183540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2018
Decision Date April 30, 2019
Days to Decision 131 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 156d · This submission: 131d
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 Peers - PNR Enteral Syringes With Enteral Specific Connectors

Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K183540.
Profoject™ Enteral Feeding Syringe
K251585 · CMT Health PTE., Ltd. · Jul 2025
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · Cardinalhealth · Dec 2024
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
Enteral Pump Syringe
K211593 · Jiangsu Caina Medical Co.,Ltd · Sep 2021