Cleared Traditional

K160419 - Monoject Enteral Feeding Syringe with E...

K160419 is the FDA 510(k) clearance for Monoject Enteral Feeding Syringe with E... by Covidien. It is a Class 2 Gastroenterology & Urology device (product code PNR) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K160419 · Covidien · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
86d
Days
Class 2
Risk

K160419 is an FDA 510(k) clearance for the Monoject Enteral Feeding Syringe with ENFit Connector. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on May 12, 2016 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien devices

Submission Details

510(k) Number K160419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date May 12, 2016
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
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

All 23
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K160419.
AMSure® Enteral Feeding Syringe with ENFit Tip
K171857 · Amsino International, Inc. · Mar 2018
Monoject Enteral Syringe with ENFit Connector
K161963 · Covidien · Sep 2016
Monoject
K161045 · Covidien · Jun 2016
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
K142128 · Covidien · Feb 2015