Cleared Traditional

K821172 - EXTERNAL FEMALE URINARY INCONTINENCE

K821172 is an FDA 510(k) clearance for EXTERNAL FEMALE URINARY INCONTINENCE, manufactured by The Healthcare Group Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821172 · The Healthcare Group Laboratories, Inc. · Gastroenterology & Urology device
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May 1982
Decision
14d
Days
Class 2
Risk

K821172 is an FDA 510(k) clearance for the EXTERNAL FEMALE URINARY INCONTINENCE. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by The Healthcare Group Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on May 10, 1982 after a review of 14 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 The Healthcare Group Laboratories, Inc. devices

FDA 510(k) Submission Details - K821172

510(k) Number K821172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1982
Decision Date May 10, 1982
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

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 85
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K821172.
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
CURITY BEDSIDE DRAINAGE BAG
K813621 · The Kendal Co. · Feb 1982
HOLLISTER FEMALE URINARY COLLECT SYS
K820234 · Hollister, Inc. · Feb 1982
ARGYLE PEDIATRIC URINE COLLECTOR
K813479 · Sherwood Medical Co. · Jan 1982