Cleared Traditional

K871528 - ENTRIMIT GRAVITY FEEDING SET

K871528 is an FDA 510(k) clearance for ENTRIMIT GRAVITY FEEDING SET, manufactured by Biosearch Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K871528 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Aug 1987
Decision
112d
Days
Class 2
Risk

K871528 is an FDA 510(k) clearance for the ENTRIMIT GRAVITY FEEDING SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 112 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.

FDA 510(k) Submission Details - K871528

510(k) Number K871528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1987
Decision Date August 10, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 131d · This submission: 112d
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 651
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K871528.
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · Abbott Laboratories · Aug 1987
INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT
K872096 · Tri-State Hospital Supply Corp. · Aug 1987
INFANT FEEDING TUBE
K872097 · Tri-State Hospital Supply Corp. · Aug 1987
MODIFIED MULTI-LUMEN NASOGASTRIC TUBE
K871691 · Bissell Medical Products, Inc. · Aug 1987
MOSS(R) GASTROSTOMY TUBE CAT #5-17719
K871554 · Mfg. and Research, Inc. · Jul 1987
ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET
K871019 · Entech, Inc. · Jun 1987
K871528 · ENTRIMIT GRAVITY FEEDING SET
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