Cleared Traditional

K875232 - INTRO-REDUCER (NASOGASTRIC TUBE)

K875232 is an FDA 510(k) clearance for INTRO-REDUCER (NASOGASTRIC TUBE), manufactured by Health Improvement Assoc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K875232 · Health Improvement Assoc. · Gastroenterology & Urology device
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Jun 1988
Decision
163d
Days
Class 2
Risk

K875232 is an FDA 510(k) clearance for the INTRO-REDUCER (NASOGASTRIC TUBE). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Health Improvement Assoc. (Freeland, US). The FDA issued a Cleared decision on June 2, 1988 after a review of 163 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 Health Improvement Assoc. devices

FDA 510(k) Submission Details - K875232

510(k) Number K875232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date June 02, 1988
Days to Decision 163 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
32d slower than avg
Panel avg: 131d · This submission: 163d
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 518
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K875232.
CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K882867 · Corpak Co. · Sep 1988
COMPAT (R) ENTERAL DELIVERY SYSTEM
K882218 · Sandoz Nutrition · Sep 1988
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K880767 · Medical Innovations Corp. · Aug 1988
DENT SLEEVE MANOMETRIC CATHETER
K881310 · Wilson-Cook Medical, Inc. · May 1988
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
K874154 · Electro-Catheter Corp. · Apr 1988
MIC (SPECIFIC LINE) REPLACEMENT KIT
K880768 · Medical Innovations Corp. · Apr 1988