Cleared Traditional

K760069 - BAG, LEG, URINE COLLECTING DEVICE

K760069 is an FDA 510(k) clearance for BAG, manufactured by Pharmaseal Div., Baxter Healthcare Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K760069 · Pharmaseal Div., Baxter Healthcare Corp. · Gastroenterology & Urology device
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Oct 1976
Decision
126d
Days
Class 2
Risk

K760069 is an FDA 510(k) clearance for the BAG, LEG, URINE COLLECTING DEVICE. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1976 after a review of 126 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 Pharmaseal Div., Baxter Healthcare Corp. devices

FDA 510(k) Submission Details - K760069

510(k) Number K760069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1976
Decision Date October 20, 1976
Days to Decision 126 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
5d faster than avg
Panel avg: 131d · This submission: 126d
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 102
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K760069.
DRAINAGE UNIT, COMBINATION
K770497 · Concord Laboratories, Inc. · Mar 1977
URINARY DRAINAGE SET, CLOSED, STERILE
K770320 · Medical Devices, Inc. · Mar 1977
URINARY LEG BAG DRAINAGE TUBE
K761039 · Pharmaseal Div., Baxter Healthcare Corp. · Dec 1976
BAG, URINE COLLECTION, CLOSED SYSTEM
K760105 · Concord Laboratories, Inc. · Oct 1976