Cleared Traditional

K151237 - Nutrisafe 2- ENFit Adaptor

K151237 is an FDA 510(k) clearance for Nutrisafe 2- ENFit Adaptor, manufactured by Vygon. The device is a Class 2 Gastroenterology & Urology device with product code PIO cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K151237 · Vygon · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
274d
Days
Class 2
Risk

K151237 is an FDA 510(k) clearance for the Nutrisafe 2- ENFit Adaptor. Classified as Enteral Specific Transition Connectors (product code PIO), Class II - Special Controls.

Submitted by Vygon (Lansdale Montgomery, US). The FDA issued a Cleared decision on February 9, 2016 after a review of 274 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Vygon devices

FDA 510(k) Submission Details - K151237

510(k) Number K151237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2015
Decision Date February 09, 2016
Days to Decision 274 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
144d slower than avg
Panel avg: 130d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PIO Device Classification - Class 2, Special Controls

Product Code PIO Enteral Specific Transition Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral 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 - PIO Enteral Specific Transition Connectors

Devices cleared under the same product code (PIO) and FDA review panel - the closest regulatory comparables to K151237.
Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
K231299 · Cair Lgl · Jan 2024
ENFit Adaptor
K233190 · Jiangsu Caina Medical Co.,Ltd · Jan 2024
Enteral Transition Adaptor
K220165 · GBUK Group, Ltd. · Oct 2022
Medline ENFit Connectors
K151628 · Medline Industries, Inc. · Jul 2015