Cleared Traditional

K872824 - P. URINE METER, 250CC

K872824 is an FDA 510(k) clearance for P. URINE METER, manufactured by Ni-Med, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K872824 · Ni-Med, Inc. · Gastroenterology & Urology device
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Oct 1987
Decision
90d
Days
Class 2
Risk

K872824 is an FDA 510(k) clearance for the P. URINE METER, 250CC. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Ni-Med, Inc. (South Lyon, US). The FDA issued a Cleared decision on October 14, 1987 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ni-Med, Inc. devices

FDA 510(k) Submission Details - K872824

510(k) Number K872824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1987
Decision Date October 14, 1987
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 103
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K872824.
KENDALL CURITY URINARY DRAINAGE BAGS
K892433 · The Kendal Co. · May 1989
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678 · Hollister, Inc. · Aug 1988
URETHAL CATHETER
K874309 · Medovations, Inc. · Dec 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610 · Coloplast A/S · Jun 1987
CONVEEN(R) LEG-BAG (600 ML)
K871643 · Coloplast A/S · Jun 1987
NORTA (TM) UROBAG
K870504 · Beiersdorf, Inc. · Apr 1987