Cleared Traditional

K130674 - ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE

K130674 is an FDA 510(k) clearance for ENTUIT THRIVE LP BALLOON RETENTION GAST..., manufactured by Xeridiem Medical Devices. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K130674 · Xeridiem Medical Devices · Gastroenterology & Urology device
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Jan 2014
Decision
306d
Days
Class 2
Risk

K130674 is an FDA 510(k) clearance for the ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Xeridiem Medical Devices (Tucson, US). The FDA issued a Cleared decision on January 13, 2014 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Xeridiem Medical Devices devices

FDA 510(k) Submission Details - K130674

510(k) Number K130674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2013
Decision Date January 13, 2014
Days to Decision 306 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
175d slower than avg
Panel avg: 131d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

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 513
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K130674.
CORGRIP
K133599 · Corpak Medsystems · Mar 2014
METRIXCARE
K132424 · The Metrix Company · Feb 2014
MACY CATHETER
K133881 · Hospi Corporation · Jan 2014
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130611 · Xeridiem Medical Devices · Dec 2013
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
K131052 · Actuated Medical, Inc. · Aug 2013
ELECTROMAGNETIC TRANSMITTING STYLET
K131532 · Corpak Medsystems · Aug 2013