Cleared Traditional

K170319 - Low Profile Non-Balloon Feeding Device

K170319 is the FDA 510(k) clearance for Low Profile Non-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 247-day FDA review.

K170319 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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Oct 2017
Decision
247d
Days
Class 2
Risk

K170319 is an FDA 510(k) clearance for the Low Profile Non-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 October 6, 2017 after a review of 247 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 K170319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2017
Decision Date October 06, 2017
Days to Decision 247 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
117d slower than avg
Panel avg: 130d · This submission: 247d
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 K170319.
Bowel Management Device, Bowel Management Irrigation Set
K180026 · Applied Medical Technology, Inc. · Jun 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
K173955 · Halyard Health, Inc. · Jan 2018
Gastric Sizing Balloon Catheter
K173355 · Cook Incorporated · Nov 2017
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