Cleared Traditional

WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET (K864364) - FDA 510(k) Clearance

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

K864364 · Technical Associates of New England · Gastroenterology & Urology device
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Feb 1987
Decision
98d
Days
Class 2
Risk

K864364 is an FDA 510(k) clearance for the WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Technical Associates of New England (Hopkinton, US). The FDA issued a Cleared decision on February 11, 1987 after a review of 98 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 Technical Associates of New England devices

Submission Details

510(k) Number K864364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date February 11, 1987
Days to Decision 98 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 faster than avg
Panel avg: 130d · This submission: 98d
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 124
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K864364.
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