Cleared Traditional

K820637 - CATH-HOLD

K820637 is an FDA 510(k) clearance for CATH-HOLD, manufactured by Womco Products. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K820637 · Womco Products · Gastroenterology & Urology device
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Mar 1982
Decision
17d
Days
Class 2
Risk

K820637 is an FDA 510(k) clearance for the CATH-HOLD. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Womco Products (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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.

FDA 510(k) Submission Details - K820637

510(k) Number K820637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date March 25, 1982
Days to Decision 17 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
114d faster than avg
Panel avg: 131d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 164
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K820637.
URETERAL CATHETER CONNECTING TUBE
K820866 · Van-Tec, Inc. · Apr 1982
URETERAL CATHETER CONNECTOR
K820868 · Van-Tec, Inc. · Apr 1982
RETRIEVAL FORCEPS
K820239 · American Endoscopy, Inc. · Mar 1982
AM. PH. STERILE SINGLE-USE URETHRAL CATH
K820419 · American Pharmaseal Div. Ahsc · Mar 1982
VANCE-JACOBELLIS MICROHEMATURIA CATHETER
K812995 · Vance Products, Inc. · Mar 1982
VPI-FAIR URETHRAL STENT
K820313 · Vance Products, Inc. · Mar 1982