Cleared Traditional

K162188 - Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) (FDA 510(k) Clearance)

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

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

Submission Details

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.

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 K162188.
Profoject Enteral/Oral Feeding Syringe
K253268 · CMT Health PTE., Ltd. · Apr 2026
Profoject™ Enteral Feeding Syringe
K251585 · CMT Health PTE., Ltd. · Jul 2025
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · Cardinalhealth · Dec 2024
Nutricair Enteral Syringe with ENFit
K231300 · Cair Lgl · Oct 2023
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