Cleared Traditional

K850664 - ENDO-TUBE

K850664 is the FDA 510(k) clearance for ENDO-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 121-day FDA review.

K850664 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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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

Submission Details

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
9d faster than avg
Panel avg: 130d · This submission: 121d
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 K850664.
E-Z-EM GASTRIC LAVAGE CATHETER
K853384 · E-Z-Em, Inc. · Nov 1985
COONS GASTROSTICK SYSTEM
K852552 · Medi-Tech, Inc. · Oct 1985
FEEDING UNITS & TUBES
K853288 · I M, Inc. · Oct 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