Cleared Traditional

K161413 - Low Profile Balloon Feeding Device

K161413 is an FDA 510(k) clearance for Low Profile Balloon Feeding Device, manufactured by Applied Medical Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K161413 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
262d
Days
Class 2
Risk

K161413 is an FDA 510(k) clearance for the Low Profile Balloon Feeding Device. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 262 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 Applied Medical Technology, Inc. devices

FDA 510(k) Submission Details - K161413

510(k) Number K161413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2016
Decision Date February 09, 2017
Days to Decision 262 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
131d slower than avg
Panel avg: 131d · This submission: 262d
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 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K161413.
Barone Jejunostomy Catheter Set
K160567 · Cook Incorporated · May 2017
Kangaroo Feeding Tube with IRIS Technology
K163002 · Covidien (Dba Medtronic) · May 2017
Flexi-Seal PROTECT Fecal Management System
K162906 · Convatec · Mar 2017
TubeClear Control Box and Clearing Stem
K163092 · Actuated Medical, Inc. · Nov 2016
CORGRIP NG/NI Tube Retention System
K162110 · Corpak Medsystems, Inc. A Division of Haylard Health · Sep 2016
Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
K160787 · Syncro Medical Innovations, Inc. · Aug 2016