Cleared Traditional

K883319 - HILL NASOGASTRIC TUBE

K883319 is an FDA 510(k) clearance for HILL NASOGASTRIC TUBE, manufactured by Zinetics Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K883319 · Zinetics Medical, Inc. · Gastroenterology & Urology device
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Dec 1988
Decision
122d
Days
Class 2
Risk

K883319 is an FDA 510(k) clearance for the HILL NASOGASTRIC TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Zinetics Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 122 days - within the typical 510(k) review window.

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 Zinetics Medical, Inc. devices

FDA 510(k) Submission Details - K883319

510(k) Number K883319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1988
Decision Date December 05, 1988
Days to Decision 122 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 130d · This submission: 122d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K883319.
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · Abbott Laboratories · Dec 1988
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT
K884309 · Biosearch Medical Products, Inc. · Dec 1988
KIM NASO-INTESTINAL TUBE
K882918 · Sheridan Catheter Corp. · Dec 1988
DENT SLEEVE MANOMETRIC CATHETER
K881310 · Wilson-Cook Medical, Inc. · May 1988
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
K874154 · Electro-Catheter Corp. · Apr 1988
MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K874936 · Medsurg Industries, Inc. · Apr 1988