Cleared Traditional

K802012 - TRIBAG

K802012 is the FDA 510(k) clearance for TRIBAG by Pollak (Intl.), Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K802012 · Pollak (Intl.), Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
20d
Days
Class 2
Risk

K802012 is an FDA 510(k) clearance for the TRIBAG, URINE BAG SYSTEM #1109,& 1301-12. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 20 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 Pollak (Intl.), Ltd. devices

Submission Details

510(k) Number K802012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date September 09, 1980
Days to Decision 20 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
110d faster than avg
Panel avg: 130d · This submission: 20d
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 73
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K802012.
BARD MALE EXTERNAL CATHETER
K802433 · C.R. Bard, Inc. · Oct 1980
URIHESIVE SYSTEM
K802172 · E. R. Squibb & Sons, Inc. · Sep 1980
URIHESIVE STRIPS
K802173 · E. R. Squibb & Sons, Inc. · Sep 1980
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