Cleared Traditional

K852619 - URI-SURE

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

K852619 · Ashai Co. , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
62d faster than avg
Panel avg: 130d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K852619.
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934 · Hollister, Inc. · Aug 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · Travenol Laboratories, S.A. · Apr 1986
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · Coloplast A/S · Dec 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · C.R. Bard, Inc. · Jul 1985
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
K844684 · Coloplast A/S · Jan 1985
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · Travenol Laboratories, S.A. · Dec 1984