Cleared Traditional

K851671 - GASTROINTESTINAL TUBE

K851671 is the FDA 510(k) clearance for GASTROINTESTINAL TUBE by Sheridan Catheter Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K851671 · Sheridan Catheter Corp. · Gastroenterology & Urology device
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Jun 1985
Decision
52d
Days
Class 2
Risk

K851671 is an FDA 510(k) clearance for the GASTROINTESTINAL TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on June 14, 1985 after a review of 52 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 Sheridan Catheter Corp. devices

Submission Details

510(k) Number K851671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date June 14, 1985
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
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 206
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K851671.
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985
ENDO-TUBE
K850664 · Biosearch Medical Products, Inc. · Jun 1985
IVAC KEOFEED II POLYURETHANE FEEDING TUBE
K850182 · Y · Mar 1985
ENTRON ENTERAL FEEDING BAG
K850134 · Biosearch Medical Products, Inc. · Feb 1985
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
K844222 · Biosearch Medical Products, Inc. · Dec 1984