Cleared Traditional

MODIFIED MULTI-LUMEN NASOGASTRIC TUBE (K871691) - FDA 510(k) Clearance

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

K871691 · Bissell Medical Products, Inc. · Gastroenterology & Urology device
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Aug 1987
Decision
103d
Days
Class 2
Risk

K871691 is an FDA 510(k) clearance for the MODIFIED MULTI-LUMEN NASOGASTRIC TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Bissell Medical Products, Inc. (Chicago, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 103 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 Bissell Medical Products, Inc. devices

Submission Details

510(k) Number K871691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1987
Decision Date August 10, 1987
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
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 123
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K871691.
BARD MOSS(R) GASTROSTOMY TUBE
K890871 · C.R. Bard, Inc. · Apr 1989
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · Abbott Laboratories · Dec 1988
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · Abbott Laboratories · Aug 1987
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
K861618 · Travenol Laboratories, S.A. · Jul 1986
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985