Cleared Traditional

K850664 - ENDO-TUBE

K850664 is an FDA 510(k) clearance for ENDO-TUBE, 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 121-day FDA review.

K850664 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
121d
Days
Class 2
Risk

K850664 is an FDA 510(k) clearance for the ENDO-TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on June 21, 1985 after a review of 121 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K850664

510(k) Number K850664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1985
Decision Date June 21, 1985
Days to Decision 121 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
10d faster than avg
Panel avg: 131d · This submission: 121d
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 K850664.
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
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
IVAC KEOFEED II POLYURETHANE FEEDING TUBE
K850182 · Y · Mar 1985