Cleared Traditional

K952187 - RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY C...

K952187 is an FDA 510(k) clearance for RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY C..., manufactured by Rusch, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K952187 · Rusch, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
77d
Days
Class 2
Risk

K952187 is an FDA 510(k) clearance for the RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on July 25, 1995 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - 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 Rusch, Inc. devices

FDA 510(k) Submission Details - K952187

510(k) Number K952187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date July 25, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOB Device Classification - Class 2, Special Controls

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - KOB Catheter, Suprapubic (and Accessories)

All 17
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K952187.
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969 · The Kendal Co. · Apr 1997
RUSCH SUPRAPUBIC TRAY
K970021 · Rusch, Inc. · Feb 1997
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · Cook Urological, Inc. · Aug 1995
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603 · Bivona Medical Technologies · May 1990
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET
K870555 · Van-Tec, Inc. · Mar 1987