Cleared Traditional

CORTRAK* 2 Enteral Access System (20-0950) (K240965) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240965 · Avanos Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
58d
Days
Class 2
Risk

K240965 is an FDA 510(k) clearance for the CORTRAK* 2 Enteral Access System (20-0950). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 6, 2024 after a review of 58 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 Avanos Medical, Inc. devices

Submission Details

510(k) Number K240965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2024
Decision Date June 06, 2024
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 130d · This submission: 58d
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 141
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K240965.
ZZIREN™ Orogastric Tube
K242901 · Tools For Surgery, LLC · Jan 2025
Entarik NI Feeding Tube System
K241169 · Gravitas Medical, Inc. · Nov 2024
CORGRIP* SR NG/NI Tube Retention System
K241185 · Avanos Medical, Inc. · Oct 2024
Stylus
K233591 · Degania Silicone , Ltd. · May 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039 · Reshape Lifesciences · May 2024
ViSiGi LUX (5332)
K234033 · Boehringer Laboratories, LLC · May 2024