Cleared Traditional

K834268 - ISLAMI GASTROINTESTINAL TUBE

K834268 is the FDA 510(k) clearance for ISLAMI GASTROINTESTINAL TUBE by Biosearch Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K834268 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Feb 1984
Decision
58d
Days
Class 2
Risk

K834268 is an FDA 510(k) clearance for the ISLAMI GASTROINTESTINAL TUBE. 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 February 4, 1984 after a review of 58 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

Submission Details

510(k) Number K834268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date February 04, 1984
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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 257
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K834268.
ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
K840752 · E-Z-Em, Inc. · May 1984
NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT
K840936 · Biosearch Medical Products, Inc. · Mar 1984
ENTERNAL FEEDING TUBE
K834562 · Sheridan Catheter Corp. · Feb 1984
NEEDLE CATHETER JEJUNOSTOMY KIT
K833513 · Biosearch Medical Products, Inc. · Nov 1983
ENTRI FLEX FEEDING TUBE
K833621 · Biosearch Medical Products, Inc. · Nov 1983
FLEXIFLO ENTERAL FEEDING TUBE
K832966 · Abbott Laboratories · Oct 1983