Cleared Traditional

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT (K161141) - FDA 510(k) Clearance

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

K161141 · Pentaferte Italia S.R.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
334d
Days
Class 2
Risk

K161141 is an FDA 510(k) clearance for the ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Pentaferte Italia S.R.L. (Campli, IT). The FDA issued a Cleared decision on March 22, 2017 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentaferte Italia S.R.L. devices

Submission Details

510(k) Number K161141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2016
Decision Date March 22, 2017
Days to Decision 334 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
204d slower than avg
Panel avg: 130d · This submission: 334d
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 24
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K161141.
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