Cleared Traditional

K935557 - URINARY DRAINAGE BAG

K935557 is an FDA 510(k) clearance for URINARY DRAINAGE BAG, manufactured by Puritas Health Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K935557 · Puritas Health Care, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
110d
Days
Class 2
Risk

K935557 is an FDA 510(k) clearance for the URINARY DRAINAGE BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 110 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 Puritas Health Care, Inc. devices

FDA 510(k) Submission Details - K935557

510(k) Number K935557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date March 07, 1994
Days to Decision 110 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
21d faster than avg
Panel avg: 131d · This submission: 110d
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 K935557.
ORION'S URINARY DRAINAGE SET
K944377 · Regulatory & Marketing Services, Inc. · Dec 1994
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
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
K931459 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993
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