Cleared Traditional

K790387 - FEEDING TUBE W/ LUBRICANT COATING

K790387 is an FDA 510(k) clearance for FEEDING TUBE W/ LUBRICANT COATING, 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 37-day FDA review.

K790387 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1979
Decision
37d
Days
Class 2
Risk

K790387 is an FDA 510(k) clearance for the FEEDING TUBE W/ LUBRICANT COATING. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 37 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 Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K790387

510(k) Number K790387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date April 04, 1979
Days to Decision 37 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
94d faster than avg
Panel avg: 131d · This submission: 37d
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 469
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K790387.
CONPHAR RECTAL TUBE-STERILE
K791268 · Conphar, Inc. · Aug 1979
CONPHAR STOMACH TUBE-STERILE
K791269 · Conphar, Inc. · Aug 1979
NUTRIFLOW NASOGASTRIC FEEDING TUBE
K790612 · Biosearch Medical Products, Inc. · May 1979
SILASTIC BRAND Q7-2091 GASTRIC SUMP TUBE
K760708 · Dow Corning Corp. Healthcare Industries Materials · Nov 1976
SILASTIC PERCUTANEOUS GASTROINTEST. TUBE
K760945 · Dow Corning Corp. Healthcare Industries Materials · Nov 1976