Cleared Traditional

CATH-HOLD (K820637) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820637 · Womco Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Womco Products devices

Submission Details

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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K820637.
DYNACOR URETHRAL CATHETER TRAY
K821970 · Medline Industries, Inc. · Jul 1982
BARDEX ALL SILICONE PEDIATRIC CATHETER
K821745 · C.R. Bard, Inc. · Jun 1982
BN-74 COATED BARDEX ALL SILICONE CATH
K821272 · C.R. Bard, Inc. · Jun 1982
PRE-FILLED SYRINGE & CYSTOFLO URINARY BG
K811924 · Travenol Laboratories, S.A. · Nov 1981
ARGYLE ROB-NELS
K810216 · Sherwood Medical Co. · Feb 1981
ARGYLE HEMATURIA BALLOON CATHETER
K802875 · Sherwood Medical Co. · Dec 1980