Cleared Traditional

K001916 - COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX

K001916 is an FDA 510(k) clearance for COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, manufactured by Novartis Nutrition Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K001916 · Novartis Nutrition Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
238d
Days
Class 2
Risk

K001916 is an FDA 510(k) clearance for the COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Novartis Nutrition Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 16, 2001 after a review of 238 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 Novartis Nutrition Corp. devices

FDA 510(k) Submission Details - K001916

510(k) Number K001916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2000
Decision Date February 16, 2001
Days to Decision 238 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
107d slower than avg
Panel avg: 131d · This submission: 238d
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 511
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K001916.
ROSS EMBRACE PUMP SET
K011467 · Ross Products · Aug 2001
GASTRIC SUCTION AND DRAINAGE CATHETER
K002838 · Bioenterics Corp. · Jul 2001
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
K011077 · Andersen Products, Inc. · May 2001
GASTRIC LAVAGE VALVE
K990365 · T-Med Vac Corporation · Jul 2000
SIGHTSURE OPERATION INDICATOR, MODEL SS301
K993358 · Medevices, Inc. · Mar 2000
NASOGASTRIC TUBE HOLDER, MODEL 160
K994300 · Dale Medical Products, Inc. · Feb 2000