Cleared Traditional

K964745 - AMSINO URINARY DRAINAGE BAG

K964745 is an FDA 510(k) clearance for AMSINO URINARY DRAINAGE BAG, manufactured by Amsino Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K964745 · Amsino Intl., Inc. · Gastroenterology & Urology device
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Mar 1997
Decision
112d
Days
Class 2
Risk

K964745 is an FDA 510(k) clearance for the AMSINO URINARY DRAINAGE BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Amsino Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 112 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 Amsino Intl., Inc. devices

FDA 510(k) Submission Details - K964745

510(k) Number K964745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1996
Decision Date March 18, 1997
Days to Decision 112 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 131d · This submission: 112d
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 100
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K964745.
AMSINO URINARY LEG BAG
K971929 · Amsino Intl., Inc. · Aug 1997
WELCON HUE-VU URINARY DRAINAGE BAG
K971764 · Welcon, Inc. · Jul 1997
LIBERTY VALVE
K964690 · Cleveland Medical Devices, Inc. · Mar 1997
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
K962652 · Customed, Inc. · Oct 1996
PROSYS LEG BAG
K952208 · Convatec, A Division of E.R. Squibb & Sons · Aug 1995
ORION'S URINARY DRAINAGE SET
K944377 · Regulatory & Marketing Services, Inc. · Dec 1994