Cleared Traditional

K771435 - URINARY LEG BAG

K771435 is the FDA 510(k) clearance for URINARY LEG BAG by Meddev International Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K771435 · Meddev International Corp. · Gastroenterology & Urology device
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Sep 1977
Decision
50d
Days
Class 2
Risk

K771435 is an FDA 510(k) clearance for the URINARY LEG BAG, STEOILE. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Meddev International Corp. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977 after a review of 50 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 Meddev International Corp. devices

Submission Details

510(k) Number K771435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date September 20, 1977
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 81
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K771435.
LEG BAG
K780878 · Abco Dealers, Inc. · Jul 1978
URINARY CATHETERIZATION SYSTEM W/O FOLEY
K780831 · Medical Devices, Inc. · Jul 1978
URI-DRAIN COMBO KIT FOR MALE INCONTINENC
K770789 · Chesebrough-Pond'S U.S.A. Co. · Oct 1977
BAG, URINARY, DRAINAGE, 2D9013
K770762 · Travenol Laboratories, S.A. · May 1977
COLLECTOR, SANI-CATCH, NO. 1010
K770672 · Concord Laboratories, Inc. · Apr 1977
COLLECTOR, SANI-CATCH, NO. 1014
K770673 · Concord Laboratories, Inc. · Apr 1977