Cleared Traditional

K831796 - URINE BAG SYSTEM

K831796 is an FDA 510(k) clearance for URINE BAG SYSTEM, manufactured by I M, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K831796 · I M, Inc. · Gastroenterology & Urology device
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Aug 1983
Decision
66d
Days
Class 2
Risk

K831796 is an FDA 510(k) clearance for the URINE BAG SYSTEM. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 66 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.

FDA 510(k) Submission Details - K831796

510(k) Number K831796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date August 08, 1983
Days to Decision 66 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
65d faster than avg
Panel avg: 131d · This submission: 66d
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 205
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K831796.
UROTRACK PLUS
K832526 · Vital Metrics, Inc. · Sep 1983
CONVEEN LEG BAG W/TUBE-DRAINAGE BAG
K832537 · Telcam Medical Devices, Inc. · Sep 1983
MORHEL CLOSED URINARY DRAINAGE SET
K831622 · Morhel Mexicana · Aug 1983
EXTERNAL INCONTINENCE CATHETER TRAVEL
K832106 · Plasco, Inc. · Jul 1983
LEG BAG EXTENTION TUBE-STERILE
K832107 · Plasco, Inc. · Jul 1983
EXTERNAL INCONTINENCE CATHETER SET-NON
K832108 · Plasco, Inc. · Jul 1983
K831796 · URINE BAG SYSTEM
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