Cleared Traditional

K162188 - Enteral Syringe with ENFit Connector (1...

K162188 is an FDA 510(k) clearance for Enteral Syringe with ENFit Connector (1..., manufactured by Vr Medical Technology. The device is a Class 2 Gastroenterology & Urology device with product code PNR cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K162188 · Vr Medical Technology · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
49d
Days
Class 2
Risk

K162188 is an FDA 510(k) clearance for the Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with E.... Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Vr Medical Technology (Kunshan, CN). The FDA issued a Cleared decision on September 22, 2016 after a review of 49 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 Vr Medical Technology devices

FDA 510(k) Submission Details - K162188

510(k) Number K162188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date September 22, 2016
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
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 24
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K162188.
Enteral Feeding Syringes with Enfit Connectors
K182649 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 2018
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
K181426 · Jiangsu Micsafe Medical Technology Co., Ltd. · Oct 2018
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
Monoject Enteral Feeding Syringe with ENFit Connector
K160419 · Covidien · May 2016