Cleared Traditional

K161413 - Low Profile Balloon Feeding Device

K161413 is the FDA 510(k) clearance for Low Profile Balloon Feeding Device by Applied Medical Technology, Inc.. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 130d · This submission: 262d
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 253
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K161413.
Navina Classic System
K170487 · Dentsply Sirona · Sep 2017
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
K160509 · Cook Incorporated · May 2017
Barone Jejunostomy Catheter Set
K160567 · Cook Incorporated · May 2017
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
K160654 · Covidien, LLC · May 2016
Peristeen Anal Irrigation System
K140310 · Coloplast A/S · Sep 2015
GastriSail Gastric Positioning System
K143088 · Covidien · Feb 2015