Cleared Traditional

K852619 - URI-SURE

K852619 is an FDA 510(k) clearance for URI-SURE, manufactured by Ashai Co. , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K852619 · Ashai Co. , Ltd. · Gastroenterology & Urology device
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Aug 1985
Decision
68d
Days
Class 2
Risk

K852619 is an FDA 510(k) clearance for the URI-SURE. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on August 27, 1985 after a review of 68 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 Ashai Co. , Ltd. devices

FDA 510(k) Submission Details - K852619

510(k) Number K852619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date August 27, 1985
Days to Decision 68 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
63d faster than avg
Panel avg: 131d · This submission: 68d
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 103
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K852619.
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
K861251 · American Medical Products, Inc. · Apr 1986
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · Coloplast A/S · Dec 1985
URI-CATH SYSTEM
K852490 · Gesco Intl., Inc. · Nov 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458 · Holter-Hausner Intl. · Aug 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · The Kendal Co. · Aug 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · C.R. Bard, Inc. · Jul 1985