Cleared Traditional

K150034 - AMT Enteral Transition Adapters

K150034 is an FDA 510(k) clearance for AMT Enteral Transition Adapters, manufactured by Applied Medical Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PIO cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K150034 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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Jun 2015
Decision
151d
Days
Class 2
Risk

K150034 is an FDA 510(k) clearance for the AMT Enteral Transition Adapters. Classified as Enteral Specific Transition Connectors (product code PIO), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on June 9, 2015 after a review of 151 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 Applied Medical Technology, Inc. devices

FDA 510(k) Submission Details - K150034

510(k) Number K150034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2015
Decision Date June 09, 2015
Days to Decision 151 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
20d slower than avg
Panel avg: 131d · This submission: 151d
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

All 8
Devices cleared under the same product code (PIO) and FDA review panel - the closest regulatory comparables to K150034.
Cedic Enteral ENFit Transition Connectors
K162254 · Cedic S.R.L. · May 2017
Nutrisafe 2- ENFit Adaptor
K151237 · Vygon · Feb 2016
Medline ENFit Connectors
K151628 · Medline Industries, Inc. · Jul 2015
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
K150010 · Cedic S.R.L. · Apr 2015
CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
K140581 · Cedic S.R.L. · Oct 2014