Cleared Traditional

K791969 - DYNACOR STERILE CLOSED SYS. DRAINAGE BAG

K791969 is the FDA 510(k) clearance for DYNACOR STERILE CLOSED SYS. DRAINAGE BAG by Medline Industries, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K791969 · Medline Industries, Inc. · Gastroenterology & Urology device
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Nov 1979
Decision
34d
Days
Class 2
Risk

K791969 is an FDA 510(k) clearance for the DYNACOR STERILE CLOSED SYS. DRAINAGE BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K791969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1979
Decision Date November 05, 1979
Days to Decision 34 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
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 64
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K791969.
BARD MALE EXTERNAL CATHETER
K802433 · C.R. Bard, Inc. · Oct 1980
BK-6010 CATHETER TUBE HOLDER
K801711 · Fred Sammons, Inc. · Aug 1980
ARGYLE RIGID URINE MEASURING/COLL. DEV.
K801522 · Sherwood Medical Co. · Jul 1980
CONPHAR FEMALE CATHETER W/BAG-STERILE
K791252 · Conphar, Inc. · Sep 1979
CONPHAR URINARY DRAINAGE BAG-2000ML
K791265 · Conphar, Inc. · Sep 1979
CONPHAR EXTERNAL CATHETER
K791245 · Conphar, Inc. · Aug 1979