Cleared Special

K243652 - Monoject™ Enteral Syringe with ENFit Connector (401SE) (FDA 510(k) Clearance)

Also includes:
Monoject™ Enteral Syringe with ENFit Connector (403SE) Monoject™ Enteral Syringe with ENFit Connector (406SE) Monoject™ Enteral Syringe with ENFit Connector (412SE) Monoject™ Enteral Syringe with ENFit Connector (435SE) Monoject™ Enteral Syringe with ENFit Connector (460SE)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243652 · Cardinalhealth · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
23d
Days
Class 2
Risk

K243652 is an FDA 510(k) clearance for the Monoject™ Enteral Syringe with ENFit Connector (401SE). Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on December 19, 2024 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardinalhealth devices

Submission Details

510(k) Number K243652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date December 19, 2024
Days to Decision 23 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 130d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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

All 33
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K243652.
Profoject Enteral/Oral Feeding Syringe
K253268 · CMT Health PTE., Ltd. · Apr 2026
Profoject™ Enteral Feeding Syringe
K251585 · CMT Health PTE., Ltd. · Jul 2025
Oral/Enteral Syringe with ENFit connector
K222772 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023
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