Cleared Traditional

HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE (K953232) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953232 · Hollister, Inc. · Gastroenterology & Urology device

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Optimized for regulatory review, auditing and printing

Aug 1995

Decision

39d

Days

Class 2

Risk

K953232 is an FDA 510(k) clearance for the HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hollister, Inc. devices

Submission Details

510(k) Number	K953232 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 10, 1995
Decision Date	August 18, 1995
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

91d faster than avg

Panel avg: 130d · This submission: 39d

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 125

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K953232.

KANGAROO FEEDING TUBE PLACMENT STYLET

K960632 · Sherwood Medical Co. · May 1996

KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT

K954429 · Sherwood Medical Co. · Mar 1996

BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES

K946249 · C.R. Bard, Inc. · Dec 1995

FLEXIFLO SIX ENTERAL NUTRITION PUMP SET

K943240 · Abbott Laboratories · Apr 1995

FLEXIFLO NASOENTERIC FEEDING TUBE

K922217 · Abbott Laboratories · Mar 1995

FLEXIFLO TUBE PLACEMENT VERIFIER

K922216 · Abbott Laboratories · Jan 1995

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K953232

Hollister, Inc.

Libertyville, IL · US

JOSEPH S TOKARZ

Regulatory profile

85 submissions 78 cleared

92% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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