Cleared Traditional

K971757 - LOW PROFILE FEEDING SET ACCESSORY

K971757 is an FDA 510(k) clearance for LOW PROFILE FEEDING SET ACCESSORY, manufactured by Applied Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K971757 · Applied Medical Technologies · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
178d
Days
Class 2
Risk

K971757 is an FDA 510(k) clearance for the LOW PROFILE FEEDING SET ACCESSORY. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technologies (Cleveland, US). The FDA issued a Cleared decision on November 7, 1997 after a review of 178 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 Technologies devices

FDA 510(k) Submission Details - K971757

510(k) Number K971757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1997
Decision Date November 07, 1997
Days to Decision 178 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
47d slower than avg
Panel avg: 131d · This submission: 178d
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 489
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K971757.
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · Applied Medical Resources · Jan 1998
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
K973893 · Applied Medical Technologies · Dec 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997
ENTERAL NUTRITION 1000 ML/500ML
K970849 · Medical Infusion Technologies, Inc. · Aug 1997
CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM
K970178 · Corpak, Inc. · Jul 1997
RPI DUAL PORT IRRIGATION ADAPTER
K964920 · Ridge Products, Inc. · Jul 1997