Cleared Traditional

K892437 - KENDALL KENGUARD URINARY LEG BAGS

K892437 is an FDA 510(k) clearance for KENDALL KENGUARD URINARY LEG BAGS, manufactured by The Kendal Co.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K892437 · The Kendal Co. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 1989
Decision
74d
Days
Class 2
Risk

K892437 is an FDA 510(k) clearance for the KENDALL KENGUARD URINARY LEG BAGS. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 74 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 The Kendal Co. devices

FDA 510(k) Submission Details - K892437

510(k) Number K892437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date June 23, 1989
Days to Decision 74 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
56d faster than avg
Panel avg: 130d · This submission: 74d
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 85
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K892437.
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
K926570 · Hollister, Inc. · May 1993
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
K913223 · Medical Device Inspection Co., Inc. · Sep 1991
URINE COLLECTOR LEG BAG
K896688 · Medline Industries, Inc. · May 1990
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