Cleared Traditional

K852535 - E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GAS...

K852535 is the FDA 510(k) clearance for E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GAS... by Tri-Med Specialties, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K852535 · Tri-Med Specialties, Inc. · Gastroenterology & Urology device
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Oct 1985
Decision
125d
Days
Class 2
Risk

K852535 is an FDA 510(k) clearance for the E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Tri-Med Specialties, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 125 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 Tri-Med Specialties, Inc. devices

Submission Details

510(k) Number K852535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date October 17, 1985
Days to Decision 125 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
5d faster than avg
Panel avg: 130d · This submission: 125d
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 280
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K852535.
COLOSHIELD KIT
K855121 · Deknatel, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985
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
ENDO-TUBE
K850664 · Biosearch Medical Products, Inc. · Jun 1985