Cleared Traditional

K162254 - Cedic Enteral ENFit Transition Connectors

K162254 is the FDA 510(k) clearance for Cedic Enteral ENFit Transition Connectors by Cedic S.R.L.. It is a Class 2 Gastroenterology & Urology device (product code PIO) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K162254 · Cedic S.R.L. · Gastroenterology & Urology device
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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.

View all Cedic S.R.L. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 130d · 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.

Regulatory Peers - PIO Enteral Specific Transition Connectors

Devices cleared under the same product code (PIO) and FDA review panel - the closest regulatory comparables to K162254.
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