Cleared Traditional

K881213 - GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER

K881213 is an FDA 510(k) clearance for GENT-L-KARE STERILE URINARY DRAINAGE BA..., manufactured by Geneva Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K881213 · Geneva Laboratories, Inc. · Gastroenterology & Urology device
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Jul 1988
Decision
129d
Days
Class 2
Risk

K881213 is an FDA 510(k) clearance for the GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 129 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 Geneva Laboratories, Inc. devices

FDA 510(k) Submission Details - K881213

510(k) Number K881213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1988
Decision Date July 28, 1988
Days to Decision 129 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
2d faster than avg
Panel avg: 131d · This submission: 129d
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 K881213.
KENDALL KENGUARD URINARY LEG BAGS
K892437 · The Kendal Co. · Jun 1989
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