Cleared Traditional

K860285 - XRO GASTRO-DUODENAL

K860285 is an FDA 510(k) clearance for XRO GASTRO-DUODENAL, manufactured by Vygon Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K860285 · Vygon Corp. · Gastroenterology & Urology device
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Feb 1986
Decision
14d
Days
Class 2
Risk

K860285 is an FDA 510(k) clearance for the XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Vygon Corp. (East Rutherford, US). The FDA issued a Cleared decision on February 11, 1986 after a review of 14 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 Vygon Corp. devices

FDA 510(k) Submission Details - K860285

510(k) Number K860285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1986
Decision Date February 11, 1986
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
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 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K860285.
NUTRI-CATH - FEEDING TUBE
K861090 · Gesco Intl., Inc. · Jun 1986
ONE TIME ENTERAL FEEDING BAG
K860818 · Acme United Corp. · May 1986
SCLEROTHERAPY INJECTION CATHETER
K860991 · Endovations · May 1986
ENTERAL FEEDING BAG
K854616 · Medovations, Inc. · Jan 1986
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986
COLOSHIELD KIT
K855121 · Deknatel, Inc. · Jan 1986