Cleared Traditional

K790174 - BK-6021 CONDOM CATHETER HOLDER

K790174 is an FDA 510(k) clearance for BK-6021 CONDOM CATHETER HOLDER, manufactured by Fred Sammons, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K790174 · Fred Sammons, Inc. · Gastroenterology & Urology device
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Feb 1979
Decision
13d
Days
Class 2
Risk

K790174 is an FDA 510(k) clearance for the BK-6021 CONDOM CATHETER HOLDER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1979 after a review of 13 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 Fred Sammons, Inc. devices

FDA 510(k) Submission Details - K790174

510(k) Number K790174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1979
Decision Date February 08, 1979
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
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 K790174.
CONPHAR URINARY DRAINAGE BAG 2000ML
K791262 · Conphar, Inc. · Aug 1979
CONPHAR LEG BAG
K791270 · Conphar, Inc. · Aug 1979
ARGYLE URINE METER
K790969 · Sherwood Medical Co. · Jun 1979
CATHETER, EXTERNAL MALE NURSING CARE
K781780 · Medi-Tech, Inc. · Dec 1978
CUTTER RESIFLEX URINE METER
K781521 · Cutter Laboratories, Inc. · Nov 1978
LEG BAG
K780878 · Abco Dealers, Inc. · Jul 1978