Cleared Traditional

K161963 - Monoject Enteral Syringe with ENFit Connector

K161963 is an FDA 510(k) clearance for Monoject Enteral Syringe with ENFit Con..., manufactured by Covidien. The device is a Class 2 Gastroenterology & Urology device with product code PNR cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K161963 · Covidien · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
45d
Days
Class 2
Risk

K161963 is an FDA 510(k) clearance for the Monoject Enteral 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 September 1, 2016 after a review of 45 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.

FDA 510(k) Submission Details - K161963

510(k) Number K161963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date September 01, 2016
Days to Decision 45 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
86d faster than avg
Panel avg: 131d · This submission: 45d
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 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 K161963.
Medela Low Dose Enteral Syringe
K161811 · Medela, Inc. · Feb 2017
U&U Enteral Syringe
K160855 · U&U Medical Technology Co, Ltd. · Nov 2016
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
K162188 · Vr Medical Technology · Sep 2016
NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
K161039 · Neomed, Inc. · Jun 2016
Monoject
K161045 · Covidien · Jun 2016
Monoject Enteral Feeding Syringe with ENFit Connector
K160419 · Covidien · May 2016