Cleared Traditional

K150010 - Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port

K150010 is an FDA 510(k) clearance for Cedic Oral/Luer Enteral ENFit Transitio..., manufactured by Cedic S.R.L.. The device is a Class 2 Gastroenterology & Urology device with product code PIO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K150010 · Cedic S.R.L. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2015
Decision
90d
Days
Class 2
Risk

K150010 is an FDA 510(k) clearance for the Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port. 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 April 2, 2015 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K150010

510(k) Number K150010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2015
Decision Date April 02, 2015
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 Consultant

Donawa Lifescience Consulting Srl
Roger Gray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PIO Enteral Specific Transition Connectors

All 8
Devices cleared under the same product code (PIO) and FDA review panel - the closest regulatory comparables to K150010.
Nutrisafe 2- ENFit Adaptor
K151237 · Vygon · Feb 2016
Medline ENFit Connectors
K151628 · Medline Industries, Inc. · Jul 2015
AMT Enteral Transition Adapters
K150034 · Applied Medical Technology, Inc. · Jun 2015
CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
K140581 · Cedic S.R.L. · Oct 2014