Cleared Traditional

K832822 - CLOSED SYS. DRAINAGE BAGS & TRAYS

K832822 is an FDA 510(k) clearance for CLOSED SYS. DRAINAGE BAGS & TRAYS, manufactured by Medline Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K832822 · Medline Industries, Inc. · Gastroenterology & Urology device
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Oct 1983
Decision
56d
Days
Class 2
Risk

K832822 is an FDA 510(k) clearance for the CLOSED SYS. DRAINAGE BAGS & TRAYS. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Walker, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 56 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 - K832822

510(k) Number K832822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date October 14, 1983
Days to Decision 56 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
75d faster than avg
Panel avg: 131d · This submission: 56d
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 190
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K832822.
PLASTIC LEG BAG
K831530 · Forever-Dry, Inc. · Jan 1984
SECURITY STRETCH BRIEF-MEDICAL
K833245 · Mb Products, Ltd. · Oct 1983
URO-TEX MALE EXTERNAL CATHETER
K832450 · Sierra Laboratories, Inc. · Oct 1983
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
K832822 · CLOSED SYS. DRAINAGE BAGS & TRAYS
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