Cleared Traditional

K875232 - INTRO-REDUCER (NASOGASTRIC TUBE)

K875232 is the FDA 510(k) clearance for INTRO-REDUCER (NASOGASTRIC TUBE) by Health Improvement Assoc.. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
33d slower than avg
Panel avg: 130d · This submission: 163d
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 292
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K875232.
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