Cleared Traditional

K851672 - NYHUS/NELSON TUBE

K851672 is an FDA 510(k) clearance for NYHUS/NELSON TUBE, manufactured by Bissell 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 77-day FDA review.

K851672 · Bissell Medical Products, Inc. · Gastroenterology & Urology device
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Jul 1985
Decision
77d
Days
Class 2
Risk

K851672 is an FDA 510(k) clearance for the NYHUS/NELSON 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 July 9, 1985 after a review of 77 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 Bissell Medical Products, Inc. devices

FDA 510(k) Submission Details - K851672

510(k) Number K851672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date July 09, 1985
Days to Decision 77 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
54d faster than avg
Panel avg: 131d · This submission: 77d
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 501
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K851672.
GASTRO-ENTEROSTOMY TUBE
K852707 · Medical Innovations Corp. · Aug 1985
MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT
K852363 · Medical Innovations Corp. · Aug 1985
CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW
K852792 · Corpak Co. · Aug 1985
ENDO-TUBE
K850664 · Biosearch Medical Products, Inc. · Jun 1985
GASTROINTESTINAL TUBE
K851671 · Sheridan Catheter Corp. · Jun 1985
CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO
K851539 · Chesebrough-Pond'S U.S.A. Co. · Jun 1985