Cleared Traditional

K190084 - McLean-Ring Enteral Feeding Tube Set

K190084 is the FDA 510(k) clearance for McLean-Ring Enteral Feeding Tube Set by Cook Incorporated. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K190084 · Cook Incorporated · Gastroenterology & Urology device
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Oct 2019
Decision
267d
Days
Class 2
Risk

K190084 is an FDA 510(k) clearance for the McLean-Ring Enteral Feeding Tube Set. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 11, 2019 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 Cook Incorporated devices

Submission Details

510(k) Number K190084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2019
Decision Date October 11, 2019
Days to Decision 267 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
137d slower than avg
Panel avg: 130d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K190084.
Standard Bougie
K191885 · Standard Bariatrics · Apr 2020
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
K193325 · Prosys International, Ltd. · Mar 2020
Navina Smart System, Navina Classic System
K190977 · Dentsply Sirona · Nov 2019
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
K191387 · Envizion Medical , Ltd. · Jun 2019
CORTRAK* 2 Equilateral Enteral Access System
K191340 · Avanos Medical, Inc. · Jun 2019
Entuit PEG, Entuit PEGJ
K183336 · Wilson-Cook Medical, Inc. · May 2019