Cleared Traditional

K151628 - Medline ENFit Connectors

K151628 is an FDA 510(k) clearance for Medline ENFit Connectors, manufactured by Medline Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PIO cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K151628 · Medline Industries, Inc. · Gastroenterology & Urology device
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Jul 2015
Decision
37d
Days
Class 2
Risk

K151628 is an FDA 510(k) clearance for the Medline ENFit Connectors. Classified as Enteral Specific Transition Connectors (product code PIO), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 24, 2015 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medline Industries, Inc. devices

FDA 510(k) Submission Details - K151628

510(k) Number K151628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2015
Decision Date July 24, 2015
Days to Decision 37 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
93d faster than avg
Panel avg: 130d · This submission: 37d
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 K151628.
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K150034 · Applied Medical Technology, Inc. · Jun 2015