Cleared Traditional

K821848 - ASSURE-MALE EXTERNAL INCONTINCE CATHETER

K821848 is the FDA 510(k) clearance for ASSURE-MALE EXTERNAL INCONTINCE CATHETER by Medical Design & Manufacturing Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K821848 · Medical Design & Manufacturing Corp. · Gastroenterology & Urology device
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Aug 1982
Decision
49d
Days
Class 2
Risk

K821848 is an FDA 510(k) clearance for the ASSURE-MALE EXTERNAL INCONTINCE CATHETER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Medical Design & Manufacturing Corp. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1982 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Medical Design & Manufacturing Corp. devices

Submission Details

510(k) Number K821848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1982
Decision Date August 10, 1982
Days to Decision 49 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
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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 - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 81
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K821848.
ADHESIVE SPRAY #4050-4060
K822307 · The Healthcare Group Laboratories, Inc. · Sep 1982
STERILE FOLEY CATHETERIZATION KITS
K821979 · Medical Devices, Inc. · Aug 1982
STERILE URETHRAL CATHETERIZATION SET
K821978 · Medical Devices, Inc. · Aug 1982
EXTERNAL URINARY MALE INCONTINENCE DEV
K821161 · The Healthcare Group Laboratories, Inc. · May 1982
URINARY COLLECTION CONTAINER/LEG BAG
K821171 · The Healthcare Group Laboratories, Inc. · May 1982
EXTERNAL FEMALE URINARY INCONTINENCE
K821172 · The Healthcare Group Laboratories, Inc. · May 1982