Cleared Traditional

K944377 - ORION'S URINARY DRAINAGE SET

K944377 is an FDA 510(k) clearance for ORION'S URINARY DRAINAGE SET, manufactured by Regulatory & Marketing Services, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K944377 · Regulatory & Marketing Services, Inc. · Gastroenterology & Urology device
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Dec 1994
Decision
90d
Days
Class 2
Risk

K944377 is an FDA 510(k) clearance for the ORION'S URINARY DRAINAGE SET. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 6, 1994 after a review of 90 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 Regulatory & Marketing Services, Inc. devices

FDA 510(k) Submission Details - K944377

510(k) Number K944377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date December 06, 1994
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 94
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K944377.
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
K972887 · Medline Industries, Inc. · Dec 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
NEEDLELESS URINE SAMPLING PORT
K944236 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1994
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · C.R. Bard, Inc. · Sep 1994
URINARY DRAINAGE BAG
K935557 · Puritas Health Care, Inc. · Mar 1994