Cleared Traditional

BIBAG (K791198) - FDA 510(k) Clearance

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

K791198 · Ab Medett Produkter · Gastroenterology & Urology device
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Jul 1979
Decision
34d
Days
Class 2
Risk

K791198 is an FDA 510(k) clearance for the BIBAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Ab Medett Produkter (Walker, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 34 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 Ab Medett Produkter devices

Submission Details

510(k) Number K791198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1979
Decision Date July 30, 1979
Days to Decision 34 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
96d faster than avg
Panel avg: 130d · This submission: 34d
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 19
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K791198.
BK-6010 CATHETER TUBE HOLDER
K801711 · Fred Sammons, Inc. · Aug 1980
ARGYLE RIGID URINE MEASURING/COLL. DEV.
K801522 · Sherwood Medical Co. · Jul 1980
DYNACOR STERILE CLOSED SYS. DRAINAGE BAG
K791969 · Medline Industries, Inc. · Nov 1979
ARGYLE URINE METER
K790969 · Sherwood Medical Co. · Jun 1979
BK-6021 CONDOM CATHETER HOLDER
K790174 · Fred Sammons, Inc. · Feb 1979
BAG, URINARY, DRAINAGE, 2D9013
K770762 · Travenol Laboratories, S.A. · May 1977