Cleared Traditional

K162254 - Cedic Enteral ENFit Transition Connectors (FDA 510(k) Clearance)

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

K162254 · Cedic S.R.L. · Gastroenterology & Urology device
May 2017
Decision
267d
Days
Class 2
Risk

K162254 is an FDA 510(k) clearance for the Cedic Enteral ENFit Transition Connectors. Classified as Enteral Specific Transition Connectors (product code PIO), Class II - Special Controls.

Submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on May 4, 2017 after a review of 267 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.

Submission Details

510(k) Number K162254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2016
Decision Date May 04, 2017
Days to Decision 267 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 156d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.