Cleared Traditional

K152857 - NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps

K152857 is an FDA 510(k) clearance for NeoMed NeoConnect Enteral Syringes with..., manufactured by Neomed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PNR cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K152857 · Neomed, Inc. · Gastroenterology & Urology device
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Dec 2015
Decision
78d
Days
Class 2
Risk

K152857 is an FDA 510(k) clearance for the NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSec.... Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Neomed, Inc. (Woodstock, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 78 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 Neomed, Inc. devices

FDA 510(k) Submission Details - K152857

510(k) Number K152857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date December 17, 2015
Days to Decision 78 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
53d faster than avg
Panel avg: 131d · This submission: 78d
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 K152857.
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
NeoMed NeoConnect Enteral Syringes with ENFit Connector
K143344 · Neomed, Inc. · Apr 2015
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
K142128 · Covidien · Feb 2015