Cleared Traditional

K133334 - VERITRACT ENTERAL FEEDING TUBE SYSTEM

K133334 is an FDA 510(k) clearance for VERITRACT ENTERAL FEEDING TUBE SYSTEM, manufactured by Veritract, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K133334 · Veritract, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
301d
Days
Class 2
Risk

K133334 is an FDA 510(k) clearance for the VERITRACT ENTERAL FEEDING TUBE SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Veritract, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 26, 2014 after a review of 301 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 Veritract, Inc. devices

FDA 510(k) Submission Details - K133334

510(k) Number K133334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2013
Decision Date August 26, 2014
Days to Decision 301 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 131d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
TIM NIEMAN

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 - KNT Tubes, Gastrointestinal (and Accessories)

All 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K133334.
AbbVie PEG
K142793 · AbbVie, Inc. · Jan 2015
AbbVie J
K142816 · AbbVie, Inc. · Jan 2015
AQUARIUS Gastrostomy Replacement Tube
K143378 · Degania Silicone , Ltd. · Dec 2014
GENERICA MEDICAL ENTERNAL DELIVERY
K133077 · Generica Medical International, Inc. · Jul 2014
AQUARIUS EXTENSION FEEDING SET
K141631 · Degania Silicone , Ltd. · Jul 2014
CONSURE STOOL MANAGEMENT SYSTEM
K133465 · Consure Medical Pvt , Ltd. · Jun 2014

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.